MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-06 for ACCESS VITAMIN B 12 REAGENT 33000 manufactured by Beckman Coulter.
[5450776]
The customer reported non-reproducible vitamin b12 (access vitamin b12) results on the access 2 immunoassay system (serial number (b)(4)) for one patient. The initial access vitamin b12 result was questioned, as the result was below the customer's normal reference range. The sample was repeated two additional times on the same access 2 immunoassay system and recovered with erratic results. One result recovered within the customer's normal reference range the second result recovered below the customer's normal reference range. The initial result was not released from the laboratory. There was no report of patient injury or change in patient treatment associated with this event. As part of trouble shooting, the customer reanalyzed the same patient's serum sample and a plasma sample that was drawn from the patient at the same time. All results recovered below the customer's normal reference range. All system parameters (including quality control (qc), calibration and system check) were within assay/instrument specifications. Beckman coulter (bec) customer technical specialist (cts) advised the customer to perform a precision test. The customer completed two fifteen (15) replicate precision runs, one using qc level one and another using qc level three. Both precision tests met assay specifications. The patient's sample was collected in a serum separator tube. Centrifugation speed, time and temperature were not supplied. No issues with sample integrity were reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
[13026913]
The customer did not provide patient demographics such as age, date of birth, sex or weight. The vitamin b12 reagent was not returned for evaluation. The cause of this event cannot be determined with the available information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2015-00147 |
| MDR Report Key | 4578056 |
| Report Source | 05,06 |
| Date Received | 2015-03-06 |
| Date of Report | 2015-02-10 |
| Date of Event | 2015-02-10 |
| Date Mfgr Received | 2015-02-10 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2015-04-07 |
| 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 | JEFFREY KOLL |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer Phone | 9523681361 |
| 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 B 12 REAGENT |
| Generic Name | RADIOASSAY, VITAMIN B12, PRODUCT CODE: CDD |
| Product Code | CDD |
| Date Received | 2015-03-06 |
| Model Number | NA |
| Catalog Number | 33000 |
| Lot Number | 434614 |
| Device Expiration Date | 2015-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-03-06 |