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

Model Number 07P7420

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2022

Event Type  malfunction  

Event Description

The customer observed falsely elevated ldh results generated on the alinity c processing module for one patient.The initial result was 731 u/l, repeated 215 and 202 u/l (normal range 125 to 220 u/l).No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

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 wiesbaden to alinity c processing module, list number 03r67-01, and manufacturing site of irving.Mdr number 3016438761-2022-00262-00 has been submitted and all further information will be documented under that mdr number.

• Brand Name: ALINITY C LACTATE DEHYDROGENASE REAGENT KIT
• Type of Device: 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: 14492296
• MDR Text Key: 292601924
• Report Number: 3002809144-2022-00178
• Device Sequence Number: 1
• Product Code: CFJ
• UDI-Device Identifier: 00380740130244
• UDI-Public: 00380740130244
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

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
• Device Operator: Health Professional
• Device Model Number: 07P7420
• Device Catalogue Number: 07P74-20
• Device Lot Number: 16138UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 06/10/2022
• Supplement Dates FDA Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC04256.; ALNTY C PROCESSING MODU, 03R67-01, AC04256.