MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-12-24 for ARCHITECT ACTIVE-B12 03P24-25 manufactured by Abbott Germany.
[20062995]
The customer observed falsely elevated active b12 results on the architect i2000sr analyzer. The following data was provided (pmol/l): (b)(6), initial 13. 5, repeats 58. 9, 71. 9, (b)(6), initial 95. 7, repeats 51. 5, 19. 5, (b)(6), initial 19. 8, repeats 34, 45. 4. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[20262049]
An evaluation is in process. A follow up report will be submitted when the evaluation is complete. (b)(4). An evaluation is in process.
Patient Sequence No: 1, Text Type: N, H10
[27540369]
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling and review of historical data. No adverse trend was identified for the customer's issue. Labeling was reviewed and found to be adequate. The customer observed an upward shift in external control results (patient samples were used as controls) with architect active-b12 reagent lot 10366up00. An analysis utilizing field data was completed to determine if the median patient values have shifted over time. The analysis showed that the median value has not changed over time and concluded that the reagent lots included in the analysis (including likely cause lot 10366up00) read patient results consistently. Also, a review of the certificate of analysis for the likely cause lot 10366up00 and the comparison lot 10351up00 found that both lots met all specifications. Based on all available information and abbott diagnostics' complaint investigation, the assay performed as intended and no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002809144-2014-00199 |
| MDR Report Key | 4361614 |
| Report Source | 01,05 |
| Date Received | 2014-12-24 |
| Date of Report | 2014-09-30 |
| Date Mfgr Received | 2015-02-23 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2015-01-12 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT GERMANY |
| Manufacturer Street | MAX-PLANCK-RING 2 |
| Manufacturer City | WIESBADEN 65205 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65205 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT ACTIVE-B12 |
| Generic Name | ACTIVE B12 |
| Product Code | CDD |
| Date Received | 2014-12-24 |
| Catalog Number | 03P24-25 |
| Lot Number | 10366UP00 |
| Device Expiration Date | 2015-05-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT GERMANY |
| Manufacturer Address | MAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-24 |