MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-01-26 for AU480 CLINICAL CHEMISTRY ANALYZER AU481-10E B12183 manufactured by Beckman Coulter, Inc.
[36848516]
Beckman customer support hotline reviewed customer data to determine that the acetaminophen (actm) calibration formula in specific test parameters was incorrect. Field application specialist was dispatched to assess the instrument and correct the calibration formula setting. There was no evidence of malfunction. Parameters are installed using a master disk. Au manufacturing reviewed original master disk copy and master disk entry logs to confirm no errors were detected. The correct calibration formula was verified on the original master. Further review of the incorrect calibration formula confirmed the only impact would be to the low or negative end of the calibration curve. Although the cause of the incorrect calibration parameter setting is unknown, correcting the calibration formula resolved the issue. No further issues have been reported. Patient demographics, such as age, date of birth or weight, were not provided. (b)(4). All other associated mdrs: patient 1 (day 1) - 9612296-2016-00010; patient 1 (day 2) - 9612296-2016-00011; patient 1 (day 3) - 9612296-2016-00012. Patient 2 - 9612296-2016-00014.
Patient Sequence No: 1, Text Type: N, H10
[36848517]
Customer reported erroneous false positive acetaminophen (actm) results generated by the au480 clinical chemistry analyzer. This mdr reports patient 1 event from (b)(6) 2016. This event will address patient 1 day 4. On (b)(6) 2016, the instrument generated elevated actm results. Customer indicated that the erroneous results were elevated but not within the toxic range. The results were reported out of the laboratory. There was reported change to patient treatment associated with this event. Patient was admitted to the hospital for alcohol intoxication and hospitalization was prolonged due to continued reports of elevated actm. Customer stated there had been no issues with actm calibration; all were passing. Customer stated there were no controls (qc) issues. Review of qc history demonstrated typical and consistent recovery that were within the facility ranges. Customer reported no issues with analyzer or with any other assay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612296-2016-00013 |
| MDR Report Key | 5390895 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-01-26 |
| Date of Report | 2016-01-12 |
| Date of Event | 2016-01-11 |
| Date Mfgr Received | 2016-01-12 |
| Device Manufacturer Date | 2015-08-01 |
| Date Added to Maude | 2016-01-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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. DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD. M/S E1.SE.01 |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| Manufacturer G1 | BECKMAN COULTER MISHIMA K.K. |
| Manufacturer Street | 454-32 HIGASHINO, NAGAIZUMI-CHO SUNTO-GUN |
| Manufacturer City | SCHIZUOKA, MISHIMA, JP-NOTA 41, JA |
| Manufacturer Country | JA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AU480 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | LDP |
| Date Received | 2016-01-26 |
| Model Number | AU481-10E |
| Catalog Number | B12183 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| 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. Hospitalization | 2016-01-26 |