MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-02-12 for ACCESS VITAMIN B12 REAGENT 33000 manufactured by Beckman Coulter.
[139066204]
The customer did not provide patient demographics such as weight, ethnicity or race. The access b12 reagent was not returned for evaluation. All assay and system verifications met specifications at the time of this incident. No hardware errors, flags or other assay issues were reported in conjunction with this event. The cause of this event cannot be determined with the available information.
Patient Sequence No: 1, Text Type: N, H10
[139066205]
On (b)(6) 2019 the customer reported that non-reproducible elevated vitamin b12 (access vitamin b12) results had been generated on the customer's unicel dxi800 immunoassay system (serial number (b)(4)) for one patient sample. The initial elevated vitamin b12 result was 219. 23 pmol/l was released from the laboratory. The sample was sent to another laboratory and repeated with an alternate method (not provided); result provided was <111 pmol/l. There was no report of change to patient care or treatment. Calibration, quality control and system check were all performing within specifications at the time of the incident. Information regarding patient sample collection and processing was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2019-01046 |
| MDR Report Key | 8331842 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-02-12 |
| Date of Report | 2019-02-12 |
| Date of Event | 2019-01-21 |
| Date Facility Aware | 2019-01-30 |
| Date Mfgr Received | 2019-01-30 |
| Date Added to Maude | 2019-02-12 |
| 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 S. KRAEMAR BLVD. |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS VITAMIN B12 REAGENT |
| Generic Name | RADIOASSAY, B12 |
| Product Code | CDD |
| Date Received | 2019-02-12 |
| Model Number | 33000 |
| Catalog Number | 33000 |
| Lot Number | 831320 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-12 |