MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-08-15 for ARCHITECT I CARBAMAZEPINE 01P36-25 manufactured by Abbott Germany.
[52070224]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[52070285]
The customer observed false elevated carbamazepine patient results generated using the architect carbamazepine reagents. The following data was provided (ug/ml). Initial >20, diluted and repeated 28. Repeat 5. 6, 28, 14. 9. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[55702982]
Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, and a review of labeling. No adverse trend was identified for the customer issue. Device history review did not identify any issues that may have caused the customer issue. Labeling was reviewed and found to be adequate. The product was not available for return. Review of field data showed the median value of the complaint lot was within the range of median values for other lots in the field between (b)(6) 2015 and (b)(6) 2016, and no issue for the complaint lot was identified. 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
[74810291]
The device evaluation was reassessed and concluded that a malfunction occurred, the device did not perform as intended. However, no systematic issue or product deficiency was identified. Conclusion code was corrected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002809144-2016-00055 |
| MDR Report Key | 5875050 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-08-15 |
| Date of Report | 2017-04-26 |
| Date Mfgr Received | 2017-04-10 |
| Device Manufacturer Date | 2015-09-17 |
| Date Added to Maude | 2016-08-15 |
| 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 | 3 |
| Event Location | 3 |
| 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 I CARBAMAZEPINE |
| Generic Name | ENZYME IMMUNOASSAY, CARBAMAZEPINE |
| Product Code | KLT |
| Date Received | 2016-08-15 |
| Catalog Number | 01P36-25 |
| Lot Number | 57085LI00 |
| Device Expiration Date | 2016-09-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-08-15 |