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 2018-11-14 for AU680 CLINICAL CHEMISTRY ANALYZER AU681-10DE, WIN7, CHEMISTRY ANALYZER AU680 FOR DIR B96695 manufactured by Beckman Coulter.
[127207591]
A beckman coulter (bec) field service engineer (fse) was sent to the customer site. The fse recalibrated and redirected qc. The patient sample was rerun on a different instrument. No system or equipment malfunction was identified and no parts were replaced. Beckman coulter internal identifier is case-(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[127207592]
The customer reported the au680 clinical chemistry analyzer generated an erroneously high procalcitonin (pct) patient result. The result was released from the lab and the patient was prescribed an antibiotic, augmentin, as a result of the erroneously high pct result. The patient was later released from hospital and no patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612296-2018-01095 |
| MDR Report Key | 8072199 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-14 |
| Date of Report | 2018-11-14 |
| Date of Event | 2018-10-17 |
| Date Facility Aware | 2018-10-18 |
| Date Mfgr Received | 2018-10-18 |
| Device Manufacturer Date | 2017-03-01 |
| Date Added to Maude | 2018-11-14 |
| 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 |
| 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 |
| Manufacturer City | NAGAIZUMI-CHO SUNTO-GUN JP-NOTA 4 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | JP-NOTA 41 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AU680 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | PRI |
| Date Received | 2018-11-14 |
| Model Number | AU681-10DE, WIN7, CHEMISTRY ANALYZER AU680 FOR DIR |
| Catalog Number | B96695 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD BREA CA 928218000 US 928218000 |
| Brand Name | AU680 CLINICAL CHEMISTRY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JJE |
| Date Received | 2018-11-14 |
| Model Number | AU681-10DE, WIN7, CHEMISTRY ANALYZER AU680 FOR DIR |
| Catalog Number | B96695 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD BREA CA 928218000 US 928218000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-14 |