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)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This issue was previously reported under mdr number 1415939-2019-00014.The incorrect manufacturing location was documented.This report was generated to document (b)(6) as the manufacture location.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely elevated lactate dehygrogenase (ldh) result while using the clinical chemistry ldh assay.The customer indicated the patient was admitted after the initial result was generated.The following results were provided: initial 1154, retest results: 214, 209 and 215 u/l no impact to patient management was reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, instrument log review, a search for similar complaints, and a review of labeling.Return material was not available.Instrument log file review did not identify an instrument issue.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 dehydrgenase assay, reagent list number 02p56, lot number 73199un18, was identified.

• Brand Name: LACTATE DEHYDROGENASE
• Common Device Name: LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8478584
• Report Number: 1628664-2019-00286
• Device Sequence Number: 1781401
• Product Code: CFJ
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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,Followup
• Report Date (Section B): 07/15/2019

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: 05/07/2019
• Device Catalogue Number: 02P56-21
• Device Lot Number: 73199UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT C8000 PROCESS MODULE; ARCHITECT C8000 PROCESS MODULE; LN 01G06-11, SN (B)(6); LN 01G06-11, SN (B)(6); ARCHITECT C8000 PROCESS MODULE; LN 01G06-11, SN (B)(4)