MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CREATININE REAGENT KIT; ALKALINE PICRATE, COLORIMETRY, CREATININE

Catalog Number	07P99-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
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.
Event or Problem Description
The customer reported a falsely elevated creatinine result generated on the alinity c processing module on a patient.The following results were provided: sid (b)(6) two primary sample tubes were drawn off-site, the customer prepared an aliquot of each tube.Aliquot 1 processed on (b)(6) 2024 creatinine = 189 umol/l (normal range: 64-110 umol/l) new sample tested on (b)(6) 2024 was normal.The customer then processed the original primary tubes and the 2 aliquots: primary tube 1 = 90.4 umol/l, primary tube 2 = 84.3 umol/l, aliquot 1 = 132.4 / 127.2 umol/l, aliquot 2 = 77 / 76.4 umol/l.No impact to patient management was reported.
Event or Problem Description
The customer reported a falsely elevated creatinine result generated on the alinity c processing module on a patient.The following results were provided: sid (b)(6) two primary sample tubes were drawn off-site, the customer prepared an aliquot of each tube.Aliquot 1 processed on (b)(6) 2024 creatinine = 189 umol/l (normal range: 64-110 umol/l) new sample tested on (b)(6) 2024 was normal.The customer then processed the original primary tubes and the 2 aliquots: primary tube 1 = 90.4 umol/l primary tube 2 = 84.3 umol/l aliquot 1 = 132.4 / 127.2 umol/l aliquot 2 = 77 / 76.4 umol/l no impact to patient management was reported.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for alinity creatinine ln 7p99 lot 88191un22.Trending review determined no trends for falsely elevated results for the product.Return testing was not completed as returns were not available.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 creatinine ln 7p99 lot 88191un22 was identified.

• Brand Name: ALINITY C CREATININE REAGENT KIT
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, CREATININE
• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18597080
• Report Number: 3002809144-2024-00021
• Device Sequence Number: 12770996
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083809
• 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): 03/12/2024

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: 06/14/2024
• Device Catalogue Number: 07P99-20
• Device Lot Number: 88191UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2023
• 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