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

Model Number	07P9920
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: multiple = sid idm (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 creatinine results for two patients.The following data was provided: sid idm (b)(6) initial result was 1106.94 umol/l, repeated 98.30 umol/l, repeated on another analyzer 93 umol/l, sid idm (b)(6) initial result 1222.26 umol/l, repeated 105 umol/l, (reference ranges for serum creatinine: men 63.6-110.5 umol/l; women 50.4-98.1 umol/l).No impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the reagent lot performs as expected for this product.Return testing was not performed as returns were not available.Trending review did not identify any trends for the complaint issue.Device history record review did not identify any issues associated with lot 97017un21 and the complaint issue.A log review of the suspect sample results indicates a possible interferent in the reaction that absorbs even if no reaction is occurring (sample + r1 rgt only).Absorbance changes when the r2 reagent is added further contributes to the final elevated result.The absorbance graph is impacted as shown by the atypical and unexpected absorbance increase at the secondary wavelength measurements.We cannot determine the exact cause of the results discrepancy.However, based on this investigation and log review the most likely cause for the initial elevated creatinine results appears to be a possible interferent.This is most likely fibrin protein present in the cuvette.This is based on the higher initial absorbance of the sample + r1 only reagent.Typically, the absorbance would be much lower as was seen on the follow up analysis that yielded the lower value.Labeling is adequate to assist the customer with reagent and sample preparation instructions and troubleshooting.Based on all reviewed data, we conclude that there is no general issue with the alinity c creatinine reagent lot identified in this complaint.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; 433331157
• MDR Report Key: 13291579
• Report Number: 3002809144-2022-00024
• Device Sequence Number: 4409465
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 02/14/2022

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: 12/17/2022
• Device Model Number: 07P9920
• Device Catalogue Number: 07P99-20
• Device Lot Number: 97017UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• 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