Device product
TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies
Z-1617-2020
Product summary
- Event
- Event 85120
- Status
- Terminated
- Classification
- Class II
- Quantity
- 88 units
- Official record key
device-enforcement:Z-1617-2020
Official wording
Reason: Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and displayed on the TEG Manager test result screen are rounded to the nearest whole number and lead to TEG Manager displaying an out of range alert when the test result is actually in range, or vice versa.
Code information: TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0, and 4.1.1.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Device software or design
Software defect