MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-11-11 for AU5400 CLINICAL CHEMISTRY ANALYZER AU5421-02 N1464100 manufactured by Beckman Coulter.
[21242007]
The customer reported obtaining erroneously elevated c reactive protein (crp) results for multiple patient samples from the au5400 clinical chemistry analyzer. The erroneous crp results were reported out of the laboratory and the customer had confirmed that one (1) patient, who was admitted to the hospital for chemotherapy, had an antibiotic treatment started as a result of the erroneously elevated crp result. Beckman coulter is unaware of any additional consequence to the patient as a result of the treatment. The customer has not received any further reports of change or affect to patient treatment. The customer indicated that no issues were noted with any other assays. The customer stated that quality control (qc) results prior to the event passed within the laboratory's established ranges. Level 1 qc result for crp was out high following the event with a result of 36. 8 mg/l and an expected target of 6. 6 mg/l. The operator concluded that level 1 qc had been incorrectly poured and subsequent repeat of the qc with a fresh qc sample generated acceptable results. All crp patient results were then reported out of the laboratory. When the customer was alerted of the erroneous crp results, the customer reviewed the patient results and repeated the patient samples. The customer stated that only six (6) samples were confirmed as elevated and eighty-three (83) results were found to have "normal or almost normal" values. The customer issued corrected reports out of the laboratory. The customer did not provide any repeat results for this event. Beckman coulter reviewed the reaction monitor's optical density (od) readings and identified that the od readings do not correspond with the generated result values. Beckman coulter re-calculated the crp results based on the od readings measured by the analyzer and determined that seventy-six (76) results were deemed erroneously high based on the re-calculation.
Patient Sequence No: 1, Text Type: D, B5
[21440608]
Beckman coulter's review of the customer's optical density readings of the crp assay between calibrations indicates stable and consistent recoveries at each level. There is no indication of a reagent issue. A field service engineer (fse) was not dispatched to the customer's site for this event; no parts were replaced, and no adjustments or alignments were performed. The customer confirmed that with the exception this event, the instrument has performed without any issues prior to and following the event. The customer has not been able to reproduce this event. In conclusion, the cause of the event is unknown; there is no evidence of a reagent or mechanical instrument malfunction. This event was isolated to crp. The complete patient identifier for this report is (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612296-2014-00135 |
| MDR Report Key | 4244461 |
| Report Source | 01,08 |
| Date Received | 2014-11-11 |
| Date of Report | 2014-10-17 |
| Date of Event | 2014-10-04 |
| Date Mfgr Received | 2014-10-17 |
| Device Manufacturer Date | 2007-11-15 |
| Date Added to Maude | 2014-11-12 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER MISHIMA K.K. |
| Manufacturer Street | 454-32 HIGASHINO NAGAIZUMI-CHO |
| Manufacturer City | SUNTO-GUN, SHIZUOKA, 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 | AU5400 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | DCK |
| Date Received | 2014-11-11 |
| Model Number | AU5421-02 |
| Catalog Number | N1464100 |
| Lot Number | NA |
| ID Number | SW VERSION 6.3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-11-11 |