MAUDE Adverse Event Report: ABBOTT GMBH LACTATE DEHYDROGENASE (LDH); NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE

Model Number	2P56-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated lactate dehydrogenase result for one patient on an architect c16000 analyzer.The following data was provided: initial result was 346.64, repeats on other analyzers were 141.08, 142.67, and 143.09 u/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The complaint investigation for a falsely elevated lactate dehydrogenase (ldh) result included a search for similar complaints, the review of complaint text, trending data, labeling, and device history records.Trending review determined no related trends for the product.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the likely cause list number and complaint issue.Manufacturing documentation for the likely cause list number was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of lactate dehydrogenase (ldh) assay, lot number 26340un21, was identified.Section g1 - contact office information updated.

• Brand Name: LACTATE DEHYDROGENASE (LDH)
• Common Device Name: NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford, IL N39 E-932 ; 2246682940
• MDR Report Key: 13064148
• Report Number: 3002809144-2021-00716
• Device Sequence Number: 4152864
• Product Code: CFJ
• UDI-Device Identifier: 00380740161460
• UDI-Public: 00380740161460
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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: 03/08/2022
• Device Model Number: 2P56-22
• Device Catalogue Number: 02P56-22
• Device Lot Number: 26340UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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: ARC C16K PRC MOD, 03L77-01, (B)(6); ARC C16K PRC MOD, 03L77-01,(B)(6)
• Patient Sex: Unknown