MAUDE Adverse Event Report: ABBOTT GMBH GLUCOSE; HEXOKINASE, GLUCOSE

Model Number	3L82-22
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased glucose result generated on the architect c4000 analyzer for one patient sample.The customer repeated the sample on another analyzer and the result was higher.The following data was provided: (b)(6) initial result = < 10 mg/dl (sodium fluoride).(b)(6) repeat result on another analyzer (ac04028) = 130 mg/dl (plasma supernatant).No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation for falsely decreased glucose results included a review of complaint activity, trending reports, device history records, labeling and field data.Return testing was not completed as returns were not available.Review of complaint and trending data did not identify any issues or trends.Review of device history records for the complaint lot did not identify any non-conformances or deviations.Labeling was reviewed and sufficiently addresses the complaint issue.A review of historical performance for reagent lot 61202uq12 was evaluated using worldwide data.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 61202uq12 is within the established control limits.Based on this investigation, no systemic issue or deficiency was identified for the glucose reagent lot 61202uq12.

• Brand Name: GLUCOSE
• Common Device Name: HEXOKINASE, GLUCOSE
• 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: 15064097
• Report Number: 3002809144-2022-00251
• Device Sequence Number: 14828807
• Product Code: CFR
• UDI-Device Identifier: 00380740161583
• UDI-Public: 00380740161583
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K060383
• 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): 08/06/2022

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: 12/31/2022
• Device Model Number: 3L82-22
• Device Catalogue Number: 03L82-22
• Device Lot Number: 61202UQ12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 08/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• 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: ARC C4000 INTGR, 02P24-40, (B)(6).; ARC C4000 INTGR, 02P24-40, (B)(6).
• Patient Sex: Unknown