MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-27 for ARCHITECT I2000SR ANALYZER 3M74-02 03M74-02 manufactured by Abbott Laboratories (irving Ia/cc).
[188259143]
During the subsequent site visit by the field service engineer (fse) the analyzer was inspected, and a part replacement was performed. A review of the analyzer service history identified no contributing factors to the current complaint. There have been no further occurrences of discrepant results after the part was replaced by the fse. A review of the immunoassay systems tracking and trending data revealed no systemic issues or trends associated with the discrepant result described in this complaint. Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue. A review of the product labeling concluded that the issue is sufficiently addressed. Based on the investigation no product deficiency was identified for the architect i2000sr serial number (b)(4). All available patient information was included. Additional patient details are not available.
Patient Sequence No: 1, Text Type: N, H10
[188259144]
The customer reported a falsely elevated architect stat troponin-i result on a (b)(6)-yr old female patient. Results provided: (b)(6) 2020 sid 007309341 = 0. 35 / 0. 00 ng/ml, another instrument = 0. 07 ng/ml. Customer's negative range: 0. 03-0. 19 ng/ml. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3016438761-2020-00015 |
| MDR Report Key | 9890759 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-14 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2020-03-27 |
| 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 LABORATORIES (IRVING IA/CC) |
| Manufacturer Street | 1915 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT I2000SR ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2020-03-27 |
| Model Number | 3M74-02 |
| Catalog Number | 03M74-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES (IRVING IA/CC) |
| Manufacturer Address | 1915 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |