MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-04 for AFINION 2 manufactured by Alere Technologies As.
[107693992]
An error has been detected in the afinion 2 software used in combination with the alere afinion acr test. Afinion 2 is cleared in the usa but has not yet been placed on the market and the problem described has only occured in markets outside u. S. The software defect results in deactivation of the temperature correction of the instrument. This temperature correction for the albumine measurements is required for the alere afinion acr test. The potential hazard is erroneous results for albumin and acr. The lack of temperature correction might give false low results at analyzer temperatures below 27 deg c and false high results above 27 deg c. The deviation from correct result is dependant on the actual analyzer temperature and thereby the room temperature where the analyzer is plazed. The table below shows the estimated impact on test results due to lack of temperature correction. Afinion 2 analyzer: temperature: 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37. Deviation of albumin and acr result due to sw error: -18 %, -16 %, -14 %, -12 %, -9 %, -7 %, -5 %, -2 %, 0 %, 2 %, 5 %, 7 %, 9 %, 12 %, 14 %, 16 %, 18 %, 21 %, 23 %.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613069-2018-00001 |
| MDR Report Key | 7486427 |
| Date Received | 2018-05-04 |
| Date Mfgr Received | 2018-02-27 |
| Date Added to Maude | 2018-05-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MONICA VALLESTAD |
| Manufacturer Street | KJELSAASVEIEN 161 |
| Manufacturer City | OSLO, 0504 |
| Manufacturer Country | NO |
| Manufacturer Postal | 0504 |
| Manufacturer G1 | ALERE TECHNOLOGIES AS |
| Manufacturer Street | P.O.BOX 6863 RODEL |
| Manufacturer City | OSLO, 0504 |
| Manufacturer Country | NO |
| Manufacturer Postal Code | 0504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AFINION 2 |
| Generic Name | ANALYZER |
| Product Code | JQT |
| Date Received | 2018-05-04 |
| Operator | MEDICAL ASSISTANT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE TECHNOLOGIES AS |
| Manufacturer Address | P.O.BOX 6863 RODEL?KKA OSLO, 0504 NO 0504 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-04 |