MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-01-01 for ACCESS VITAMIN B12 33000 manufactured by Beckman Coulter.
[5115888]
The customer reported obtaining an erroneous vitamin b12 result for one patient sample on the laboratory's unicel dxi 600 access immunoassay system (serial number (b)(4)). The initial result obtained was >1500 pg/ml, which was reported out of the laboratory. The patient was expected to be within the normal reference range for vitamin b12. The sample was diluted 1:5 and re-analyzed on the same instrument, which yielded 453 pg/ml, which was in the normal reference range. There is no report of patient injury or change to patient treatment in connection with this event. The sample was centrifuged at 3000 rpm for 8 minutes. System check passed on (b)(4) 2014. The customer sent the patient sample to beckman coulter for sample interference testing. Reference range for access vitamin b12: 180 - 914 pg/ml.
Patient Sequence No: 1, Text Type: D, B5
[12631314]
The customer did not provide the patient's weight. There is no indication that the access vitamin b12 reagent used by the customer was returned for evaluation. Beckman coulter analysis of the patient sample indicated evidence of alkaline phosphatase (alp) interference, as vitamin b12 was reduced by 74% with the addition of alp blocker. The instructions for use for access vitamin b12 does not include a limitation for alp interference.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2015-00001 |
| MDR Report Key | 4376635 |
| Report Source | 05,06 |
| Date Received | 2015-01-01 |
| Date of Report | 2014-12-02 |
| Date of Event | 2014-12-02 |
| Date Mfgr Received | 2014-12-02 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-01-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS VITAMIN B12 |
| Generic Name | RADIOASSAY, VITAMIN B12 |
| Product Code | CDD |
| Date Received | 2015-01-01 |
| Model Number | NA |
| Catalog Number | 33000 |
| Lot Number | 430162 |
| Device Expiration Date | 2015-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-01 |