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 2016-05-03 for ACCESS VITAMIN B12 33000 manufactured by Beckman Coulter.
[44342646]
The customer did not provide patient demographics such as age, date of birth, sex, and weight. \ the access vitamin b12 reagent was not returned for evaluation. A beckman coulter (bec) field service engineer (fse) checked the instrument and found no significant errors. The fse inspected all precision pumps, belts, rotors, and cleaned the seals. The fse performed pipettor matching, low volume pipettor matching, and system check; all passed within specifications. No hardware malfunctions were identified that may have caused, or contributed, to this event. The cause of the imprecise access vitamin b12 results could not be determined with the information available.
Patient Sequence No: 1, Text Type: N, H10
[44342647]
The customer reported obtaining non-reproducible vitamin b12 (access vitamin b12) results for six (6) patient samples. Testing was performed on the laboratory's unicel dxi 800 immunoassay system, serial number (b)(4). This report will address the results for the six (6) patient samples (designated as patient 1 - patient 6) obtained on (b)(6) 2016. The initial results were released from the laboratory. There was no change in patient treatment associated with this event. System check performed before patient testing was within specifications. Assay calibration performed before patient testing was within assay and instrument specifications. Quality control (qc) results were within specifications before patient testing on (b)(6) 2016. The customer reported that patient samples were collected in serum separator tubes. Centrifugation time, speed, and temperature were not provided. There was no indication of sample integrity issues related to this event. A beckman coulter (bec) field service engineer (fse) was dispatched to the customer's site to evaluate the instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2016-00248 |
| MDR Report Key | 5628515 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-03 |
| Date of Report | 2016-04-07 |
| Date of Event | 2016-04-07 |
| Date Mfgr Received | 2016-04-07 |
| Device Manufacturer Date | 2015-11-09 |
| Date Added to Maude | 2016-05-03 |
| 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 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 | 2016-05-03 |
| 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 553181084 US 553181084 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-03 |