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 2016-07-07 for ACCESS AFP REAGENT 33211 manufactured by Beckman Coulter.
[48961974]
The customer did not supply any patients demographics such as ages, dates of birth, sexes or weights. (b)(6). A beckman coulter (bec) field service engineer (fse) was not dispatched to the customer's site. No hardware errors, flags or other assay issues were reported in conjunction with this event. There is no evidence that the access afp reagent was returned for evaluation. One reagent pack only was identified as generating erroneous low patient results. Replacing the reagent pack questioned by an alternate reagent pack from the same lot resolved the issue. In conclusion, the cause of the event cannot be determined with the available information.
Patient Sequence No: 1, Text Type: N, H10
[48961975]
The customer reported obtaining non-reproducible low alpha fetoprotein (access afp) results for seventeen (17) patients involving the laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)). The customer reanalyzed the patient's samples on the same unicel dxi 800 access immunoassay system using a new reagent pack of access afp and obtained higher results for all seventeen (17) patients. The low access afp results were not released from the laboratory. There was no report of patient injury or change in patient treatment associated with this event. Assay calibration was recovering within specifications at the time of the event. Access afp qc (quality control) was out of specifications low at the time of the event. The customer was able to obtain passing access afp qc using the new access afp reagent pack. Information on the collection and centrifugation of the patient samples was not supplied. No issues with sample integrity were reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2016-00336 |
| MDR Report Key | 5775135 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-07-07 |
| Date of Report | 2016-06-13 |
| Date of Event | 2016-06-10 |
| Date Mfgr Received | 2016-06-13 |
| Device Manufacturer Date | 2015-07-27 |
| Date Added to Maude | 2016-07-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS ANGELA KILIAN |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer Phone | 9523681330 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA 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 AFP REAGENT |
| Generic Name | KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER |
| Product Code | LOJ |
| Date Received | 2016-07-07 |
| Model Number | NA |
| Catalog Number | 33211 |
| Lot Number | 529696 |
| Device Expiration Date | 2017-02-28 |
| 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 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-07 |