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

Model Number 120706

Device Problem High Test Results (2457)

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

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

The analyzer was returned to hemocue ab for investigation.The investigation concluded that the analyzer performed according to specification, the customer problem could not be confirmed.

Event Description

Hemocue received a complaint that the analyzer are giving false high results.Results from one patient was received, the hemocue glucose 201 showed 70 mg/dl, the patient were sent to the hospital where the lab test showed 35 mg/dl.

Manufacturer Narrative

The investigation found that the retained cuvette lots measured slightly too low at glucose level of 43 mg/dl (whole blood) and thus the customer problem could not be confirmed.No cause was found to the customer problem.

Manufacturer Narrative

Added information catalog and lot numbers for microcuvettes.Only one expiration date was possible to enter, see below for more information: lot number 1810428 - expiration date 07/18/2019, lot number 1808252 - expiration date 05/15/2019, lot number 1801668 - expiration date 10/18/2018.

• 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: 8548764
• MDR Text Key: 145658910
• Report Number: 3003044483-2019-00008
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2018
• Device Model Number: 120706
• Device Catalogue Number: 110723
• Device Lot Number: 1810428, 1808252, 1801668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 05/15/2019; 05/15/2019
• Supplement Dates FDA Received: 06/05/2019; 06/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2017
• 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