MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC LACTATE DEHYDROGENASE

Catalog Number	02P56-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This issue was previously reported under mdr number 1415939-2018-00152.The incorrect manufacturing location was documented in the original report.This report was generated to document (b)(4) as the manufacture location.(b)(6).Further investigation of the customer issue included a review of the complaint text, an instrument log review, a search for similar complaints, design history record (dhr) review, and a review of labeling.Return material was not available.A review of tracking and trending did not identify an adverse trend for issue observed by the customer.The dhr review did not identify any potential non-conformances, non-conformances or deviations related to the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information no deficiency of the clinical chemistry ldh assay, reagent list number 02p56, lot 99549un18, 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 2 patients (reference range 125 to 220 u/l): patient 1: initial 303, retests: 238, 218, 300 and 295 u/l; patient 2: initial 349, retests: 214, 205 and 206.No impact to patient management was reported.

• Brand Name: LACTATE DEHYDROGENASE
• Common Device Name: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8261501
• Report Number: 1628664-2019-00040
• Device Sequence Number: 2056879
• Product Code: CFJ
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2019

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: 02/19/2019
• Device Catalogue Number: 02P56-21
• Device Lot Number: 99549UN18
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1