MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-06-19 for ACCESS? 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter, Inc..
[2030883]
The customer contacted beckman coulter, inc. (bci) to report a higher than expected result for progesterone for 1 patient sample assayed with access progesterone reagent on an access 2 immunoassay system. The patient result was reported out of the laboratory and questioned by a nurse. The customer is unsure whether or not patient care was impacted due to the erroneous result. The customer repeated the progesterone assay for the patient sample and obtained a similar result. The customer then recalibrated the progesterone assay with a new lot of reagent and repeated the progesterone assay for the patient sample. The recalibrated assay yielded a lower progesterone result for the patient sample which more closely reflected the clinical presentation of the patient. Quality control results both before and after recalibration with the new lot of reagent were all within established ranges. The customer sent the patient sample to bci for additional analysis (results pending). A definitive root cause has not yet been determined for this event.
Patient Sequence No: 1, Text Type: D, B5
[9012866]
Erroneous data generated. A definitive root cause has not yet been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-01813 |
| MDR Report Key | 2133164 |
| Report Source | 06 |
| Date Received | 2011-06-19 |
| Date of Report | 2011-05-18 |
| Date of Event | 2011-05-17 |
| Date Mfgr Received | 2011-05-18 |
| Device Manufacturer Date | 2010-09-30 |
| Date Added to Maude | 2011-09-19 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS? 2 IMMUNOASSAY SYSTEM |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | MXZ |
| Date Received | 2011-06-19 |
| Catalog Number | 81600N |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-19 |