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	05/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated ldh results generated on the architect c16000 processing module (sn (b)(4) for one patient.The following data was provided: sid (b)(6).Initial result (sn (b)(4) 295 u/l, repeated on another instrument (sn (b)(4) 683 and 979 u/l same sample repeated again on (c1601491) 303 and 314 u/l, repeated on (sn (b)(4) 309 u/l no impact to patient management was reported.
Additional Manufacturer Narrative
Patient identifier: sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The lot search review did not identify an increase in complaint activity for the issue.Return testing was not performed as returns were not available.Device history record review was performed on lot 91126un21, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends for the complaint issue.Labeling is adequate information for the operator to prepare samples for ldh analysis.Use error may have contributed to the customer¿s issue as sample preparation is extensively covered in the instructions for use.Log analysis shows sample preparation may be the most likely cause.Based on all reviewed data, we conclude that there is no product deficiency with the ldh reagent identified in this complaint.

• 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 N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14464073
• Report Number: 3002809144-2022-00174
• Device Sequence Number: 4637608
• Product Code: CFJ
• UDI-Device Identifier: 00380740161460
• UDI-Public: 00380740161460
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 08/23/2022

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: 09/02/2022
• Device Model Number: 2P56-22
• Device Catalogue Number: 02P56-22
• Device Lot Number: 91126UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• 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