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 2016-03-04 for ACCESS VITAMIN B12 33000 manufactured by Beckman Coulter.
[39689488]
The customer did not provide patient demographics such as date of birth and weight for patients designated as patient 2 and patient 3. The vitamin b12 reagent was not returned for evaluation. The cause of the imprecise vitamin b12 results could not be determined with the information available. All related mdr reports: mdr 2122870-2016-00125, mdr 2122870-2016-00126. Beckman coulter internal identifier for this report is (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[39689489]
The customer reported obtaining non-reproducible vitamin b12 (access vitamin b12) results for three (3) patient samples. Testing was performed on the laboratory's access 2 immunoassay system portion of the unicel dxc 600i synchron access clinical system, serial number (b)(4). This report will address two (2) of the patient results (designated as patient 2 and patient 3) obtained on (b)(6) 2016. The customer did not report a change in patient treatment associated with this event. The initial result for patient 2 was above the normal reference range of the assay and not consistent with previous patient sample results. The customer reanalyzed the sample on the same access 2 immunoassay system portion of the unicel dxc 600i synchron access clinical system three times. The repeat results were within the normal reference range of the assay. The initial result was reported outside the laboratory. The initial result for patient 3 was within the normal reference range of the assay, but not consistent with previous patient sample results. The customer reanalyzed the sample on the same access 2 immunoassay system portion of the unicel dxc 600i synchron access clinical system three times. The repeat results were within the normal reference range of the assay. The initial result was reported outside the laboratory. Calibrations were performing within assay and instrument specifications before and after this event. Quality control (qc) results were not within specifications before patient testing on (b)(6) 2016. System check performed after patient testing was within specifications. A precision study performed after this event generated results that met the assay precision claim. Service was not dispatched for this event. The customer reported that patient samples were collected offsite in serum separator tubes. Upon arrival in the laboratory, samples were centrifuged for ten (10) minutes at room temperature; the speed of the centrifuge was not reported. There was no indication of sample integrity issues related to this event. Mdr 2122870-2016-00125 will address one (1) additional patient (designated as patient 1); results were obtained on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2016-00126 |
| MDR Report Key | 5480670 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-03-04 |
| Date of Report | 2016-02-07 |
| Date of Event | 2016-02-06 |
| Date Mfgr Received | 2016-02-07 |
| Device Manufacturer Date | 2015-11-09 |
| Date Added to Maude | 2016-03-04 |
| 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. JEFFREY KOLL |
| Manufacturer Street | 1000 HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 553181084 |
| Manufacturer Country | US |
| Manufacturer Postal | 553181084 |
| Manufacturer Phone | 9523681361 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 553181084 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 553181084 |
| 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 | 2016-03-04 |
| Model Number | NA |
| Catalog Number | 33000 |
| Lot Number | 531850 |
| Device Expiration Date | 2016-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 553181084 US 553181084 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-04 |