MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-10-19 for ACCESS VITAMIN B12 REAGENT 33000 manufactured by Clare Discrete Mfg Io.
[124319646]
The access vitamin b12 reagent was not returned for evaluation. A beckman coulter field service engineer was dispatched to the customer site and completed routine troubleshooting activities but did not identify any system or hardware issues that would have contributed to the issue. An assignable cause for the questioned results cannot be determined due to insufficient information.
Patient Sequence No: 1, Text Type: N, H10
[124319710]
The customer reported obtaining non-reproducible vitamin b12 (access vitamin b12) patient results on their unicel dxi 800 access immunoassay system (s/n: (b)(4)). The customers patient results were lower than the normal range of the assay. Ten patient samples were sent to an alternate facility for testing and nine of the samples recovered within the normal range of the assay. One patient sample was reproducible and recovered low on repeat. There was a change in patient treatment. An unknown number of patients were administered vitamin b12 injections based on the false low vitamin b12 results. Quality controls (qc) recovered intermittently in and out of specifications. No issues with sample integrity were reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680746-2018-01000 |
| MDR Report Key | 7984456 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-19 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-07-20 |
| Date Mfgr Received | 2018-07-20 |
| Device Manufacturer Date | 2018-03-31 |
| Date Added to Maude | 2018-10-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID DAVIS |
| Manufacturer Street | 250 SOUTH KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| Manufacturer G1 | CLARE DISCRETE MFG IO |
| Manufacturer Street | LISMEEHAN O'CALLAGHAN MILLS |
| Manufacturer City | CLARE |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS VITAMIN B12 REAGENT |
| Generic Name | RADIOASSAY, VITAMIN B12 |
| Product Code | CDD |
| Date Received | 2018-10-19 |
| Model Number | 33000 |
| Catalog Number | 33000 |
| Lot Number | 871058 |
| Device Expiration Date | 2019-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLARE DISCRETE MFG IO |
| Manufacturer Address | LISMEEHAN O'CALLAGHAN'S MILLS CLARE EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-19 |