MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-21 for HEMOCUE HB 201+ SYSTEM 121721 manufactured by Hemocue Ab.
[139440678]
The analyzer was sent to hemocue ab where the customer problem was confirmed, it was discovered that the eeprom memory had been corrupted. 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.
Patient Sequence No: 1, Text Type: N, H10
[139440679]
Hemocue ab received a complaint that the analyzer will not power on and was showing error codes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003044483-2019-00007 |
| MDR Report Key | 8439781 |
| Date Received | 2019-03-21 |
| Date of Report | 2019-03-21 |
| Date of Event | 2019-01-14 |
| Date Mfgr Received | 2019-03-04 |
| Device Manufacturer Date | 2014-08-11 |
| Date Added to Maude | 2019-03-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MARIA FAGERBERG |
| Manufacturer Street | KUVETTGATAN 1 |
| Manufacturer City | 26271 |
| Manufacturer Country | SW |
| Manufacturer Postal | 26271 |
| Manufacturer G1 | HEMOCUE AB |
| Manufacturer Street | KUVETTGATAN 1 |
| Manufacturer City | 26271 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 26271 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCUE HB 201+ SYSTEM |
| Generic Name | HEMOGLOBIN TEST SYSTEM |
| Product Code | GKR |
| Date Received | 2019-03-21 |
| Returned To Mfg | 2019-02-07 |
| Model Number | 121721 |
| Catalog Number | 121721 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEMOCUE AB |
| Manufacturer Address | KUVETTGATAN 1 ?NGELHOLM, SK?NE 26271 SW 26271 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-21 |