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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identification: sids (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 observed falsely elevated alinity c lactate dehydrogenase results for two samples.The following data was provided (reference range provided: 125 to 220), units of measure = u/l): (b)(6) 2021 sid (b)(6) initial result = 831, repeats = 286 and 222 (b)(6) 2021 sid (b)(6) initial result = 201, repeats = 171, 157, and 156 (b)(6) 2021 sid (b)(6) initial result = 268, repeats = 326 and 313 the results generated were from an automatic 1:3 dilution that was programed on the instrument.The samples were not run undiluted.Additional laboratory data was provided by the customer: sid (b)(6): platelet count = 800 sid (b)(6): platelet count = 212 sid (b)(6): platelet count = 559.
Event or Problem Description
The customer observed falsely elevated alinity c lactate dehydrogenase results for two samples.The following data was provided (reference range provided: 125 to 220), units of measure = u/l): (b)(6) 2021 sid (b)(6) initial result = 831, repeats = 286 and 222.(b)(6) 2021 sid (b)(6) initial result = 201, repeats = 171, 157, and 156.(b)(6) 2021 sid (b)(6) initial result = 268, repeats = 326 and 313.The results generated were from an automatic 1:3 dilution that was programed on the instrument.The samples were not run undiluted.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity c lactate dehydrogenase results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Trending review did not identify any trends for the issue for the product.Device history record review for lot 24339un21 did not identify any non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.Based on our investigation, no systemic issue or deficiency with the alinity c lactate dehydrogenase reagent lot 24339un21 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
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12882019
• Report Number: 3002809144-2021-00676
• Device Sequence Number: 20107529
• Product Code: CFJ
• UDI-Device Identifier: 00380740130244
• UDI-Public: 00380740130244
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/12/2022

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: 03/08/2022
• Device Model Number: 07P7420
• Device Catalogue Number: 07P74-20
• Device Lot Number: 24339UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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: ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Sex: Unknown