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

Model Number	2P56-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated ldh results generated on the architect c16000 processing module.The following results were provided (reference range 125 to 243 u/l): sid (b)(6) initial result was 893 u/l, no repeat result provided.Sid (b)(6) initial result was 872 u/l, no repeat result provided.Sid (b)(6) initial result was 905 u/l, no repeat result provided.No impact to patient management was reported.
Additional Manufacturer Narrative
Patient identifier: multiple = sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Corrected information can be found in section d4 catalogue number, changed from 02p56-21 to 02p56-22.
Additional Manufacturer Narrative
A search by lot number did not find elevated complaint activity.Return testing was not completed as returns were not available.Trending review did not identify any trends for the complaint issue.Device history record review did not identify any issues associated with lot 81714un21 and the complaint issue.The customer found foam in the bottle and determined that was the likely cause for elevated results.As part of troubleshooting, the r2 bottle was replaced, the sample was retested, and results obtained were within range.Labeling was reviewed and was found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the cc ldh reagent lot 81714un21 was identified.Corrected data found in section g1.

• Brand Name: LACTATE DEHYDROGENASE (LDH)
• Common Device Name: NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford, IL N39 E-932 ; 2246682940
• MDR Report Key: 12915576
• Report Number: 1415939-2021-00051
• Device Sequence Number: 11220108
• Product Code: CFJ
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 01/24/2022

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: 01/12/2022
• Device Model Number: 2P56-21
• Device Catalogue Number: 02P56-22
• Device Lot Number: 81714UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 01/04/2022; 01/04/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 12/16/2021; 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• 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, C1602141; ARC C16K PRC MOD, 03L77-01, C1602141; ARC C16K PRC MOD, 03L77-01, C1602141
• Patient Sex: Unknown