MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-04-15 for AU680 CLINICAL CHEMISTRY ANALYZER AU681-10E B12188 manufactured by Beckman Coulter, Inc.
[16987581]
The customer reported obtaining erroneously low, negative phosphorus (phos) results for multiple patient samples involving the au680 clinical chemistry analyzer. All erroneously low results generated error flags that identified the results as below the analytical range of the assay. Erroneous results were reported out of the laboratory. While most patients had no change to treatment, this mdr reports the event for one patient that was treated for the low phos with iv (intravenous) dose of phos. Customer indicated that controls (qc) before the event were within facility established ranges, but qc results after the event also demonstrated the negative, low results and were out of facility ranges. Customer repeated all samples after troubleshooting and issued corrected reports. There has been no report of any adverse consequences noted for the patient treated for the low phos results.
Patient Sequence No: 1, Text Type: D, B5
[17188727]
Beckman coulter customer service technician (cts) instructed customer to verify that the phosphorus reagent bottles were properly seated or supported in the refrigerated reagent compartment. Customer found that the reagent bottles were leaning and not secured. Customer properly secured the reagent, performed acceptable calibration and quality control recovery was within the facility's ranges. No further issues have been reported. No hardware components were replaced. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612296-2015-00039 |
| MDR Report Key | 4695363 |
| Report Source | 05,06 |
| Date Received | 2015-04-15 |
| Date of Report | 2015-03-19 |
| Date of Event | 2015-03-18 |
| Date Mfgr Received | 2015-03-19 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2015-04-16 |
| 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 | MR. DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD. M/S E1.SE |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7142649714 |
| Manufacturer G1 | BECKMAN COULTER MISHIMA K.K. |
| Manufacturer Street | 454-32 HIGASHINO, NAGAIZUMI-CHO |
| Manufacturer City | SUNTO-GUN, SCHIZUOKA, JP-NOTA 411-0931 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 411-0931 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AU680 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | CEO |
| Date Received | 2015-04-15 |
| Model Number | AU681-10E |
| Catalog Number | B12188 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-15 |