MAUDE Adverse Event Report: HEMOCUE AB GLUCOSE 201+ ANALYZER; HEMOCUE GLUCOSE 201+ ANALYZER

Model Number 110718

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2015

Event Type  malfunction  

Event Description

The complaint concerned a glucose 201+ analyzer (b) that on some occasions has showed deviating results when compared to another hemocue glucose 201+ analyzer (a).The (b) analyzer was used on neonates and it showed consistently lower results than the other analyzer.No pt impact is reported.A false low result could potentially lead to an unnecessary med intervention.

Manufacturer Narrative

The glucose 201+ system is not on the us market; however, a similar system, the glucose 201 system, is available on the us market, 510 (k) # k020935.The investigation is still ongoing, thus no cause has yet been determined.

• Brand Name: GLUCOSE 201+ ANALYZER
• Type of Device: HEMOCUE GLUCOSE 201+ ANALYZER
• Manufacturer (Section D): HEMOCUE AB; angelholm ; SW
• Manufacturer Contact: maria fagerberg, ra mgr ; po box 1204; angelholm 26223 ; SW 26223 ; 31481346
• MDR Report Key: 4563442
• MDR Text Key: 5547223
• Report Number: 3003044483-2015-00013
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2015
• Device Model Number: 110718
• Device Catalogue Number: 120717
• Device Lot Number: 1410541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2010
• 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