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 2020-03-03 for ACCESS ACCUTNI+3 REAGENT A98264 manufactured by Beckman Coulter.
[188140223]
The full patient identifier for this report is case-(b)(6). The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race. The device was not returned for evaluation. All assay and system verifications met specifications at the time of the event. No hardware errors, flags or other assay issues were reported in conjunction with the event. A beckman coulter (bec) field service engineer (fse) was dispatched in association with this event but did not identify a hardware, software or system issue that would have contributed to this event. In conclusion, the cause of this event cannot be determined with the available information.
Patient Sequence No: 1, Text Type: N, H10
[188140224]
On february 21, 2020 the customer reported that a non-reproducible elevated access troponin i (access accutni+3) result of 0. 356 ng/ml was generated on the laboratory's dxi 800 immunoassay analyzer (part number a71456 and serial number (b)(4)) for one patient at approximately 06:30am. The initial elevated result was released from the laboratory. The customer reported that the physician questioned the result and the patient was redrawn; the redrawn sample was tested at 08:30am and a result of 0. 032 ng/ml was obtained. The customer also reported that the original sample was retested and a result of 0. 056 ng/ml was obtained. The customer did not provide reference ranges. The beckman coulter access accutni+3 reference range is 0. 00 - 0. 04 ng/ml. Customer reported treatment was provided to the patient but customer could not provide details of treatment administered. A written attempt was made to obtain additional information regarding treatment but to date no additional information has been received. Calibration, quality control and system check parameters were all recovering with expected ranges at the time of the event. Samples were collected in becton dickinson (bd)'s green top lithium heparin tubes. Samples were full draws. Customer stated the specimen was not hemolyzed and was clear. Customer also stated that the samples were centrifuged on the beckman automation line and customer did not know the centrifugation speed or time. No other sample processing or handling information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2020-00020 |
| MDR Report Key | 9781097 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-21 |
| Date Facility Aware | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-11-01 |
| Date Added to Maude | 2020-03-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. HARRY LONG |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE M/S R590C |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer Phone | 9523681224 |
| Manufacturer G1 | BECKMAN COULTER |
| 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 ACCUTNI+3 REAGENT |
| Generic Name | IMMUNOASSAY METHOD, TROPONIN SUBUNIT |
| Product Code | MMI |
| Date Received | 2020-03-03 |
| Model Number | A98264 |
| Catalog Number | A98264 |
| Lot Number | 921318 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-03 |