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 2017-05-18 for LACTATE DEHYDROGENASE 02P56-21 manufactured by Abbott Manufacturing Inc.
[75519867]
Ticket searches determined that there is normal complaint activity for likely cause lot 25802un16. Tracking and trending report review for the architect lactate dehydrogenase assay determined that there are no related adverse or non-statistical trends. A batch record review was completed which included review of the certificate of analysis for the likely cause lot. This review indicated that the lot passed all acceptance requirements. Labeling was reviewed and sufficiently addresses the customer's issue. The customer's instrument logs were reviewed. This review found the beginning of the reaction curve for the elevated result was too high. Additionally, multiple occurrences of aspiration errors and instrument hard stops were identified. Use error may have contributed to the customer's issue. Error codes identified during the instrument log review indicate a possible sample handling issue and or dirty cuvettes which may contribute to false elevated results. A systemic issue and or product deficiency was not identified.
Patient Sequence No: 1, Text Type: N, H10
[75519868]
The account generated a falsely elevated architect lactate dehydrogenase (ldh) of 1724. 8 u/l on a patient sample that repeated 158. 5 and 155. 3 u/l in (b)(6) 2017. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00221 |
| MDR Report Key | 6574992 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-05-18 |
| Date of Report | 2017-05-18 |
| Date of Event | 2017-01-11 |
| Date Mfgr Received | 2017-04-26 |
| Device Manufacturer Date | 2016-04-28 |
| Date Added to Maude | 2017-05-18 |
| 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 MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LACTATE DEHYDROGENASE |
| Generic Name | LACTATE DEHYDROGENASE |
| Product Code | CFJ |
| Date Received | 2017-05-18 |
| Catalog Number | 02P56-21 |
| Lot Number | 25802UN16 |
| Device Expiration Date | 2017-02-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-18 |