MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-22 for LACTATE DEHYDROGENASE 02P56-21 manufactured by Abbott Manufacturing Inc.
[139714589]
This issue was previously reported under mdr number 1415939-2017-00050. The incorrect manufacturing location was documented in the original report. This report was generated to document (b)(4) as the manufacture location. Further investigation of the customer issue included a review of the complaint text, in-house testing, instrument log review, a search for similar complaints, and a review of labeling. Return material was not available. In house testing protocol was executed; the assay files for the reagent lot number was successfully calibrated and each validity control replicate generated was within the established ranges. It was determined the reagent lot is performing acceptably. Tracking and trending did not identify an adverse trend. Labeling was reviewed and found to be adequate. Based on the available no product deficiency of the clinical chemistry lactate dehydrogenase assay, reagent list number 02p56 , lot number 47148un15, was identified.
Patient Sequence No: 1, Text Type: N, H10
[139714590]
The customer observed falsely elevated lactate dehydrogenase (ldh) results while using the clinical chemistry ldh assay. The customer provided the following results for chemotherapy patient that is partaking in a clinical trial. Additional patient results are in question but no additional result data was provided. On (b)(6) 2016 (plasma): initial 431u/l, retest 298u/l, 196u/l. The customer is concerned that if the results stay high the patient may need to end their participation in the study. However, no impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2019-00246 |
| MDR Report Key | 8446089 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-22 |
| Date of Event | 2016-06-01 |
| Date Mfgr Received | 2019-03-22 |
| Device Manufacturer Date | 2015-12-01 |
| 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 | 47148UN15 |
| Device Expiration Date | 2016-10-13 |
| 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 |