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	01/08/2021
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 alinity c lactate dehydrogenase (ldh) results on one patient.The results provided were: on (b)(6) 2021 sid (b)(6) initial ldh = 247u/l (reference range 125-220u/l)/ retest one hour later = 153u/l and 140u/l.There was no reported impact to patient management.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from alinity c lactate dehydrogenase reagent kit, list number 07p74-20, and manufacturing site abbott gmbh, max-planck-ring 2, wiesbaden, germany, 65205 in section d of this report to alinity c processing module, list number 03r67-01, and manufacturing site of abbott gmbh, max-planck-ring 2, wiesbaden, germany, 65205.Mdr number 3002809144-2021-00114-00 has been submitted and all further information will be documented under that mdr number.After further evaluation, the suspect medical device was changed from alinity c lactate dehydrogenase reagent kit, list number 07p74-20, and manufacturing site abbott gmbh, max-planck-ring 2, wiesbaden, germany, 65205 in section d of this report to alinity c processing module, list number 03r67-01, and manufacturing site of abbott gmbh, max-planck-ring 2, wiesbaden, germany, 65205.Mdr number 3002809144-2021-00114-00 has been submitted and all further information will be documented under that mdr number.

• 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: 11250446
• Report Number: 3002809144-2021-00067
• Device Sequence Number: 11638377
• Product Code: CFJ
• UDI-Device Identifier: 00380740130244
• UDI-Public: 00380740130244
• 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: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

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: 07P7420
• Device Catalogue Number: 07P74-20
• Device Lot Number: 83393UN20
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 02/26/2021
• 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, AC02351; ALNTY C PROCESSING MODU, 03R67-01, AC02351; ALNTY C PROCESSING MODU, 03R67-01, (B)(4)