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

Model Number 3L82-22

Device Problem Low Readings (2460)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

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
• Type of Device: 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
• MDR Text Key: 300214580
• Report Number: 3002809144-2022-00251
• Device Sequence Number: 1
• Product Code: CFR
• UDI-Device Identifier: 00380740161583
• UDI-Public: 00380740161583
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, (B)(6).; ARC C4000 INTGR, 02P24-40, (B)(6).