MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY LACTATE DEHYDROGENASE; 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	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for patient identifier = (b)(6).
Event or Problem Description
The customer reported false elevated architect ldh results for a patient.Sample id (b)(6) generated an initial result of 997.5 u/l and retest results of 168.5 u/l and 161 u/l.The same sample was ran on two other analyzers and generated results of 167 and 163 u/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Review of the complaint activity for the lactate dehydrogenase assay did not identify any adverse or non-statistical trends.A search from similar complaints associated with lot 73199un18 only identified one other complaint.The customers instrument logs were reviewed.This review found level 2 and 3 quality controls were ran and within the expected ranges.Manufacturing documentation for the assay did not identify any issues.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the lactate dehydrogenase assay was identified.

• Brand Name: CLINICAL CHEMISTRY LACTATE DEHYDROGENASE
• Common Device Name: LACTATE DEHYDROGENASE,
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8290951
• Report Number: 1628664-2019-00074
• Device Sequence Number: 13988514
• Product Code: CFJ
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 03/20/2019

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: 01/11/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 03/20/2019
• 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 C16000 ANALYZER, LN 03L77-01; ARCHITECT C16000 SYSTEM, LN 03L77-01; SERIAL (B)(6) ; SERIAL (B)(6)
• Patient Age: 49 YR