MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C GLUCOSE REAGENT KIT; HEXOKINASE, GLUCOSE

Model Number	07P5530
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
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.
Event or Problem Description
The customer observed falsely depressed alinicy c glucose results for one patient.The initial result was >800 mg/dl, repeated with 1:5 dilution and the result was 315 mg/dl; the initial sample was repeated and the result was >800 mg/dl, repeated with 1:5 dilution and the result was 845 mg/dl.The customer is questioning the 1:5 dilution result of 315 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labelling review, and device history record review.Return testing was not completed as returns were not available.A review of tickets determined that there is normal complaint activity for lot 58159uq09.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review did not identify any issues associated with the complaint lot and the complaint issue.A review of the product labeling concluded that the issue is sufficiently addressed.File sample analysis was not performed as the qc results were within expected ranges during the reported issue indicating the product performed as expected.As part of troubleshooting, the sample was retested and gave a result that aligned with the initial result of > 800 mg/dl.The instrument was checked by the field service engineer (fse) as part of troubleshooting and after replacements and adjustments, the repeatability test results were acceptable.Based on the investigation no product deficiency was identified for the alinity c glucose reagent (ln 7p55-30) lot 58159uq09.

• Brand Name: ALINITY C GLUCOSE REAGENT KIT
• Common Device Name: HEXOKINASE, GLUCOSE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11895114
• Report Number: 3002809144-2021-00338
• Device Sequence Number: 1390117
• Product Code: CFR
• UDI-Device Identifier: 00380740135454
• UDI-Public: 00380740135454
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K170316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 06/28/2021

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 Expiration Date: 09/30/2021
• Device Model Number: 07P5530
• Device Catalogue Number: 07P55-30
• Device Lot Number: 58159UQ09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 06/28/2021
• 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, (B)(4); ALNTY C PROCESSING MODU, 03R67-01, (B)(4)