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 Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2020
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.There was no additional patient information provided by the customer due to privacy issues.
Event or Problem Description
The customer reported falsely elevated ldh results on one patient generated on the architect analyzer.The results provided were: on (b)(6) 2020 (b)(6) initial ldh on serial number (b)(4) (normal range 125-220u/l) / retest on sn (b)(4).There was no reported impact to patient management.
Additional Manufacturer Narrative
A review of similar complaint tickets could not be performed as the ldh reagent lot number was unknown.Trending review determined no trends for falsely elevated results for the product.Return testing was not completed as returns were not available.The patient sample was retested on the same instrument and acceptable results were generated.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the lactate dehydrogenase (ldh) reagent, list number 2p56 was identified.

• 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
• MDR Report Key: 11077031
• Report Number: 3002809144-2020-01212
• Device Sequence Number: 3260429
• Product Code: CFJ
• UDI-Device Identifier: 00380740161460
• UDI-Public: 00380740161460
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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 Model Number: 2P56-22
• Device Catalogue Number: 02P56-22
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 01/20/2021
• 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, C1600600; ARC C16K PRC MOD, 03L77-01, C1600600; ARC C16K PRC MOD, 03L77-01, C1600600