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

Model Number 110716

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

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

Event Date 10/29/2014

Event Type  malfunction  

Event Description

False low measurement results, results close to 0 mg/dl, are obtained with lot# 1407345 of the hemocure glucose 201 microcuvettes.No patient impact has been reported.

Manufacturer Narrative

Complaint investigation has been performed on retained samples by the manufacturer on the same lot of hemocue glucose 201 microcuvette.The problem has been confirmed, i.E.False low results are obtained.The results obtained is "0" or very close to "0" mg/dl (or 0.0 mmol/l).The result of "0" md/dl or "0" mmol/l is obtained independently on the actual glucose level of the sample.The root cause investigation has verified that the reagent in the microcuvettes does not contain any enzymes and thus no reaction in the microcuvette takes place upon filling with whole blood.The problem is due to a human error in the production of the reagent.Corrective actions has been implemented to prevent this problem to recur on other lots.Note: model# 110716 of the hemocue glucose 201 microcuvettes are not sold on the us market.However, other models are on the us market.

• Brand Name: HEMOCUE GLUCOSE 201 SYSTEM
• Type of Device: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): HEMOCUE AB; angelholm ; SW
• Manufacturer Contact: maria fagerberg, manager ; p.o box 1204; angelholm SE-26-223 ; SW SE-26223 ; 31481346
• MDR Report Key: 4293361
• MDR Text Key: 5274194
• Report Number: 3003044483-2014-00014
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K020935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2015
• Device Model Number: 110716
• Device Lot Number: 1407345
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1