MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-10 for ARCHITECT I2000SR ANALYZER 03M74-01 manufactured by Abbott Manufacturing Inc.
[31097114]
(b)(4). A followup report will be submitted when the evaluation is complete. Evaluation in process.
Patient Sequence No: 1, Text Type: N, H10
[31097115]
The account generated a positive architect bhcg of 119 u/l on a patient sample id (b)(6) who initially generated a negative result on the architect i2000sr. A new sample tested architect bhcg negative. Both samples were repeated again with negative architect bhcg results. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[33596073]
The field service engineer (fse) was dispatched to the account and performed a review of the quality control and noted the b-hcg level 1 control was high on the first run after the false positive result. A variety of maintenance and diagnostic checks were performed and a failure was observed on the wz valve pressure check for wash zone 1. The replacement of a restricted wash zone 1 manifold valve by the field service representative led to the resolution of the issue. Subsequent field service actions related to the performance of the b-hcg assay included replacing a contaminated/dirty stat probe and replacing wz manifold with valves, fep tips due to excessive buildup on the wz 1 manifold nozzles. The evaluation was performed by reviewing the complaint text, instrument service history, tracking and trending metrics, and the current labeling for both the architect system operations manual, and the architect b-hcg package insert. The architect system operations manual provides information for the troubleshooting and concerning erratic / discrepant results, including, but not limited to, the troubleshooting performed by the field service engineer. The architect b-hcg package inserts provide information regarding sample handling, result interpretation, and performance characteristics. An evaluation was performed by reviewing historical quality data, and the review did not identify any trend of the manifold valve. The issue was resolved through standard troubleshooting procedures. Based on the evaluation, the architect i2000sr analyzer is performing acceptably.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2015-00282 |
| MDR Report Key | 5216106 |
| Date Received | 2015-11-10 |
| Date of Report | 2015-12-14 |
| Date of Event | 2015-10-14 |
| Date Mfgr Received | 2015-11-17 |
| Device Manufacturer Date | 2007-01-08 |
| Date Added to Maude | 2015-11-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| 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 | NAL |
| Date Received | 2015-11-10 |
| Catalog Number | 03M74-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| 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 | 2015-11-10 |