MAUDE Adverse Event Report: HEMOCUE AB HEMOCUE HB 201 DM SYSTEM; HEMOGLOBIN TEST SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 12/12/2018

Event Type  Injury  

Event Description

Hemocue (b)(4) received a complaint stating that the customer wrongly used a blood sugar poct machine, glucose 201 dm analyzer, to check the hb value during surgery due to a mix-up of the two types of analyzers (glucose 201 dm and hb 201 dm).Consequently the anaesthetist requested (and patient was administered) 2 units of o negative blood as the result on the machine said 5.9.The patient was unnecessarily administered 2 units of o negative blood during surgery and later 2 units of ffp was given on clinical grounds.

Manufacturer Narrative

Investigation at hemocue ab concluded that the analyzers and microcuvettes were designed according to specifications, the product name is clearly visible on the analyzers and the microcuvette packages and pouches are differentiated by different "color codes", red for hb and blue for glucose.The customer confirmed that the analyzers worked as intended as they were very recently serviced and as well confirmed it has been a human error by the operator (agency staff) in handling the devices used during surgery.Additional training has been conducted at customer site.

• Brand Name: HEMOCUE HB 201 DM SYSTEM
• Type of Device: HEMOGLOBIN 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: 8235579
• MDR Text Key: 132786435
• Report Number: 3003044483-2019-00005
• Device Sequence Number: 1
• Product Code: GKR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K041234
• 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
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other