MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for HEMOCUE HB 201+ SYSTEM 121769 manufactured by Hemocue Ab.
[131920184]
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.
Patient Sequence No: 1, Text Type: N, H10
[131920585]
Hemocue (b)(4) received a complaint that the analyzer was showing error code e25.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003044483-2019-00001 |
| MDR Report Key | 8207750 |
| Date Received | 2019-01-02 |
| Date of Report | 2019-03-21 |
| Date of Event | 2018-10-16 |
| Date Mfgr Received | 2019-03-11 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2019-01-02 |
| 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 | ANGELHOLM, SKANE 26271 |
| Manufacturer Country | SW |
| Manufacturer Postal | 26271 |
| Manufacturer G1 | HEMOCUE AB |
| Manufacturer Street | KUVETTGATAN 1 |
| Manufacturer City | ANGELHOLM, SKANE 26271 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 26271 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEMOCUE HB 201+ SYSTEM |
| Generic Name | HEMOGLOBIN TEST SYSTEM |
| Product Code | GKR |
| Date Received | 2019-01-02 |
| Returned To Mfg | 2018-11-07 |
| Model Number | 121769 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEMOCUE AB |
| Manufacturer Address | KUVETTGATAN 1 ANGELHOLM, SKANE 26271 SW 26271 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-02 |