MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2010-12-02 for ARCHITECT I2000SR ANALYZER 3M74-01 manufactured by Abbott Manufacturing, Inc..
[1651723]
The customer states that a false positive result has been generated on one sample from a non-immunized pregnant female patient tested with the architect toxo igg assay. The sample generated an initial result of 13 iu/ml that retested at 0. 1 / 0. 1 iu/ml. No suspect results were reported from the lab. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[8871263]
(b)(4). To evaluate the customer issue, a review was conducted of the complaint text, the instrument history, and architect system labeling. A definite cause of the erratic toxo igg result was not found. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. The architect system operations manual ((b)(4)) and the architect toxo igg reagent package insert ((b)(4)) both contain information to address the customer's current issue. Based on the available information, a product malfunction was not identified. After reprocessing the controls and recalibrating the reagent, the results were repeated within the expected ranges. Review of complaint tracking and trending; abbott customer technical advocate initiated troubleshooting with customer intervention.
Patient Sequence No: 1, Text Type: N, H10
[8904735]
(b)(4). An investigation is in process. A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2010-00455 |
| MDR Report Key | 1913121 |
| Report Source | 01 |
| Date Received | 2010-12-02 |
| Date of Report | 2010-11-30 |
| Date of Event | 2010-11-26 |
| Date Mfgr Received | 2010-12-27 |
| Device Manufacturer Date | 2005-12-13 |
| Date Added to Maude | 2011-12-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI KONDOS RN, BSN |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 09B9, AP50 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 8479375120 |
| Manufacturer G1 | ABBOTT MANUFACTURING, INC. |
| Manufacturer Street | 1921 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 | LGS |
| Date Received | 2010-12-02 |
| Catalog Number | 3M74-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-02 |