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 2019-03-22 for LACTATE DEHYDROGENASE 02P56-21 manufactured by Abbott Manufacturing Inc.
[139706828]
This event was previously reported in manufacturer report number 1415939-2017-00093. The manufacturer location was incorrectly documented. This report is being filed. Further investigation of the customer issue included a review of the complaint text, inhouse testing, instrument log review, a search for similar complaints, and a review of labeling. Returned material was available but not returned. The assay files were successfully calibrated and each validity control replicate generated was within the established ranges demonstrating the reagent lot is performing within specification. A review of the instrument logs confirmed that an error code was generated during the timeframe the customer generated the discrepant result. This error could indicate the presence of bubbles, foam, or fibrin in the sample. Tracking and trending did not identify an adverse trend. Labeling was reviewed and found to be adequate. Based on the available information no product deficiency of the clinical chemistry lactate dehydrogenase (ldh) assay,ln 02p56, lot number 47146un15, was identified.
Patient Sequence No: 1, Text Type: N, H10
[139706829]
The customer observed falsely elevated lactate dehygrogenase (ldh) results while using the clinical chemistry ldh assay. The customer provided the following results: patient 1: (no sid provided) initial 121, retest 93 sid: (b)(6), initial 641, retest 279 and 315, sid: (b)(6), initial 1286, retest 279 and 219, sid: (b)(6), initial 636, retest 251 and 251. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2019-00245 |
| MDR Report Key | 8446018 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-22 |
| Date Mfgr Received | 2019-03-22 |
| Device Manufacturer Date | 2015-11-01 |
| Date Added to Maude | 2019-03-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 DEHYGROGENASE |
| Product Code | CFJ |
| Date Received | 2019-03-22 |
| Catalog Number | 02P56-21 |
| Lot Number | 47146UN15 |
| Device Expiration Date | 2016-08-21 |
| 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 | 2019-03-22 |