MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2009-03-11 for CLINICAL CHEMISTRY CARBAMAZEPINE 1E12-20 manufactured by Abbott Manufacturing, Inc..
[1075609]
The customer stated a patient generated a result of <0. 5 mg/l on the architect clinical chemistry carbamazepine assay. This result was reported and questioned by the pharmacist. The sample was run in duplicate two days later with results of 9. 3 and 9. 6 mg/l. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[8189806]
(b)(4). The investigation consisted of a review of the complaint information, service history review of the customer's architect c8000 instrument (b)(4), a review of carbamazepine reagent lot 63009hw00 release data, a review of the architect system operations manual, and a review of the carbamazepine package insert (b)(4). The complaint text states on (b)(6), 2009, a serum sample generated an erratic result for carbamazepine of <0. 5 mg/dl. The sample was rerun on (b)(6), 2009, and generated results of 9. 3 and 9. 6 mg/dl. The initial result was run with qc and 2 other patient samples. The qc was within specification and the two other patient results were fine. A service history review of (b)(4) did not show any instrument issues at the time of the incident. Review of the lot release data for carbamazepine reagent lot 63009hw00 shows all results were within specifications. The architect system operations manual does contain troubleshooting information for erratic results. Probable causes include sample integrity. The carbamazepine package insert also contains information for specimen collection and handling. Based on the information provided, no deficiency of the carbamazepine reagent lot 63009hw00 was found. Because this sample was run with qc and two other patient samples that were acceptable, the most likely cause of the erratic result is sample integrity. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
[8219072]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2009-00019 |
| MDR Report Key | 1340014 |
| Report Source | 01,07 |
| Date Received | 2009-03-11 |
| Date of Report | 2009-02-16 |
| Date of Event | 2009-02-09 |
| Date Mfgr Received | 2009-03-26 |
| Device Manufacturer Date | 2008-03-31 |
| Date Added to Maude | 2009-04-13 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI KONDOS RN, BSN |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 09B9, AP50 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 8479375120 |
| Manufacturer G1 | ABBOTT MANUFACTURING, INC. |
| Manufacturer Street | 820 MISSION ST. |
| Manufacturer City | SOUTH PASADENA CA 91030 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91030 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINICAL CHEMISTRY CARBAMAZEPINE |
| Generic Name | FOR THE QUANTITATION OF CARBAMAZEPINE IN HUMAN SERUM OR PLASMA |
| Product Code | KLT |
| Date Received | 2009-03-11 |
| Catalog Number | 1E12-20 |
| Lot Number | 63009HW00 |
| Device Expiration Date | 2010-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US 91030 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-11 |