MAUDE Adverse Event Report: HEMOCUE AB HEMOCUE GLUCOSE 201 SYSTEM; GLUCOSE TEST SYSTEM

Model Number 120706

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

This report was originally submitted on 21st feb 2018, however it was accidentally submitted in the test environment rather than the production environment.As advised by the cdrh, this re-submission is to correct that.

Event Description

Hemocue has received a complaint concerning the deviating blood glucose result for a patient who presented to the er with diabetic ketoacidosis.Hemocue glucose 201 system showed hhh (higher than measuring range) consistently on hourly measurements from 10pm to 6am which corresponded to the lab value at this time which was over 700mg/dl.At 7am the hemocue glucose 201 system showed a glucose concentration of 143 mg/dl but the corresponding lab value was still above 600 mg/dl.At 8am the hemocue glucose 201 system gave a value of 217 mg/dl and the lab value was still above 600 mg/dl customer stopped using the system at this point due to the deviating results.No patient impact has been reported due to the hemocue result.

Manufacturer Narrative

The analyzer and microcuvettes from the customer have still not been received for investigation.Review of batch documentation (dhr) for the analyzer and the microcuvettes found nothing related to the customer problem.Additional questions have been sent to the customer, however, despite 3 reminders no response was received.The customer has also been requested to return the analyzer for investigation, however it is uncertain whether the analyzer will be returned for review and no microcuvettes will be returned for review.The investigation was performed on retained microcuvettes from the same lot as the ones used by the customer.There was no malfunction found in the retained microcuvettes.No further investigation can be performed without receiving the analyzer, microcuvettes or answers from the customer.

• Brand Name: HEMOCUE GLUCOSE 201 SYSTEM
• Type of Device: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): HEMOCUE AB; kuvettgatan 1; ängelholm, skåne 26271 ; SW 26271
• Manufacturer (Section G): HEMOCUE AB; kuvettgatan 1; ängelholm, skåne 26271 ; SW 26271
• Manufacturer Contact: maria fagerberg ; kuvettgatan 1; ängelholm, skåne 26271 ; SW 26271
• MDR Report Key: 7298631
• MDR Text Key: 101255057
• Report Number: 3003044483-2018-00001
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2018
• Device Model Number: 120706
• Device Catalogue Number: 110706
• Device Lot Number: 1709408
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1