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

Model Number 121704

Device Problems Computer Software Problem (1112); Solder Joint Fracture (2324)

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

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

The analyzer was sent to hemocue (b)(4) where the customer problem was confirmed, it was discovered that the eeprom memory had been corrupted.The customer has not received any faulty measurements but the initial investigation shows that potentially the corruption could in the worst case lead to faulty measurement results.Root cause investigation is ongoing.

Event Description

Hemocue (b)(4) received a complaint that the analyzer does not stay on when using batteries.

Manufacturer Narrative

The root cause was found to be a glitch in the connection between components on the main board which has caused read and write errors leading to corrupt values in eeprom memory.The error in eeprom memory will be permanent if the root cause is happening in combination with other identified scenarios leading to potential incorrect measurements values.Corrective action is to improve the soldering process of components on the main board.Note, when the root cause is not occurring in a combination with the identified scenarios it will lead to an error code and no results will be displayed.

• Brand Name: HEMOCUE HB 201+ SYSTEM
• Type of Device: HEMOGLOBIN TEST SYSTEM
• Manufacturer (Section D): HEMOCUE AB; kuvettgatan 1; angelholm, skane 26271 ; SW 26271
• Manufacturer (Section G): HEMOCUE AB; kuvettgatan 1; angelholm, skane 26271 ; SW 26271
• Manufacturer Contact: maria fagerberg ; kuvettgatan 1; angelholm, skane 26271 ; SW 26271
• MDR Report Key: 8207755
• MDR Text Key: 131772088
• Report Number: 3003044483-2019-00002
• Device Sequence Number: 1
• Product Code: GKR
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K032203
• 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: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 121704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2017
• 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