MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC LACTATE DEHYDROGENASE; LACTATE DEHYGROGENASE

Catalog Number	02P56-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: LACTATE DEHYDROGENASE
• Common Device Name: LACTATE DEHYGROGENASE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8446089
• Report Number: 1628664-2019-00246
• Device Sequence Number: 19345827
• Product Code: CFJ
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2016
• Device Catalogue Number: 02P56-21
• Device Lot Number: 47148UN15
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1