MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-27 for ARCHITECT ICARBAMAZEPINE 01P36-27 manufactured by Abbott Germany.
[74146455]
Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided. Investigation of the customer issue included a review of the complaint text, review of validated instrument data analytics, batch record review, a search for similar complaints, and a review of labeling. Return material was not available. No upshift of the median value could be observed for the complaint lot. The batch record review did not identify any non-conformances or deviations. Tracking and trending did not identify an adverse trend. Labeling was reviewed and found to be adequate. Based on the available information a product deficiency of the architect icarbamazepine reagent, list number 01p36, lot number 60736li00 was not identified.
Patient Sequence No: 1, Text Type: N, H10
[74146456]
The customer observed falsely elevated carbamazepine results while using the architect carbamazepine assay. Therapeutic range 4. 0 - 12. 0ug/ml, >20. 0ug/ml toxic. The customer provided the following results (ug/ml): sid (b)(6): (b)(6) 2016: initial > 15 (flagged result), retested (1:4 dilution) 50. 40. Retested using new reagent pack: 10. 61. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002809144-2017-00047 |
| MDR Report Key | 6525467 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-27 |
| Date of Report | 2017-04-27 |
| Date of Event | 2016-08-21 |
| Date Mfgr Received | 2017-04-10 |
| Device Manufacturer Date | 2016-01-18 |
| Date Added to Maude | 2017-04-27 |
| 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 ICARBAMAZEPINE |
| Generic Name | CARBAMAZEPINE |
| Product Code | KLT |
| Date Received | 2017-04-27 |
| Catalog Number | 01P36-27 |
| Lot Number | 60736LI00 |
| Device Expiration Date | 2016-12-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-04-27 |