MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-04 for ARCHITECT STAT HIGH SENSITIVE TROPONIN-I 03P25-27 manufactured by Abbott Ireland Diagnostics Division Longford.
[181983936]
All available patient information has been included. No additional patient details are available. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[181983937]
The customer reported a false elevated troponin result of 322. 9 pg/ml, when processing on the architect i2000. The patient was treated with anticoagulant therapy after the initial result was reported to the physician. The type of anticoagulant therapy is unknown. The retest result was 10 pg/ml. The initial sample was sent to another lab and they reported a low test result. The customer also stated they have not been informed on the current state of the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005094123-2020-00065 |
| MDR Report Key | 9785669 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-03-04 |
| 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 | CHRISTIAN LEE |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224668-294 |
| Manufacturer G1 | ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD |
| Manufacturer Street | LISNAMUCK CO. LONGFORD |
| Manufacturer City | LONGFORD NA |
| Manufacturer Country | EI |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT STAT HIGH SENSITIVE TROPONIN-I |
| Generic Name | TROPONIN-I |
| Product Code | MMI |
| Date Received | 2020-03-04 |
| Catalog Number | 03P25-27 |
| Lot Number | 09197UI00 |
| Device Expiration Date | 2020-04-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD |
| Manufacturer Address | LISNAMUCK CO. LONGFORD LONGFORD NA EI NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-04 |