MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C LACTATE DEHYDROGENASE REAGENT KIT; NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE

Model Number	07P7420
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: multiple (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated that a physician questioned falsely elevated alinity c lactate dehydrogenase ( (b)(4)) results on one patient.The results obtained from the samples from the same patient collected on (b)(6) 2020 were: sid (b)(6) 215.5 u/l, 212.1 u/l, 210.1 u/l; sid (b)(6) 243.1 u/l, 565.5 u/l, 226.0 u/l.No impact to patient management was reported.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for ldh reagent lot 53885un20.Review of tracking and trending reports did not identify any related trends for the issue for the product.Return testing was not completed as returns were not available.The patient sample was retested on the same instrument and another alinity with acceptable results generated.File sample testing was not performed as the original sample generated correct results upon retesting.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 alinity c lactate dehydrogenase (ldh) reagent, lot number 53885un20 was identified.

• Brand Name: ALINITY C LACTATE DEHYDROGENASE REAGENT KIT
• 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: 11010817
• Report Number: 3002809144-2020-01185
• Device Sequence Number: 17203999
• Product Code: CFJ
• UDI-Device Identifier: 00380740130244
• UDI-Public: 00380740130244
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: EXEMPT
• 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): 01/07/2021

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 Expiration Date: 01/23/2021
• Device Model Number: 07P7420
• Device Catalogue Number: 07P74-20
• Device Lot Number: 53885UN20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/07/2021
• 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: ALNTY C PROCESSING MODU, 03R67-01, AC01143; ALNTY C PROCESSING MODU, 03R67-01, AC01143