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 2017-02-02 for ARCHITECT I2000SR ANALYZER 03M74-02 manufactured by Abbott Manufacturing Inc.
[66476194]
An evaluation is in process. A followup report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[66476195]
The account generated (b)(6) architect (b)(6) results on a patient processed on the architect i2000sr. Initially, the patient tested architect (b)(6) (1. 06 index) but repeated (b)(6) (0. 7 index) with a new sample. The new sample was repeated several days later with (b)(6) results (1. 0 index). The patient is (b)(6) with high avidity. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[74720924]
A field service engineer (fse) replaced the valve, manifold kit for leaking and the valve, syringe for clogged/obstructed to resolve the issue. However; the fse considered the likely cause of the discrepant result issue to be the valve, syringe. A review of the architect i2000sr serial (b)(4) service history verified no reports of discrepant results since the part was replaced. The architect system operations manual provides information for the troubleshooting and maintenance concerning erratic results, including, but not limited to, the troubleshooting performed by the fse. The architect cmv igm package insert provides information regarding sample handling, result interpretation, and performance characteristics. A review of the architect i2000sr tracking and trending data in the revealed no systemic issues or adverse trends associated with the erratic result issue described in this complaint. The architect i2000sr erratic result rate is within acceptable limits with no trends identified. Also, a review for similar complaints identified no adverse trends of the valve, syringe. Use error may have contributed to the customer's issue as the first sample was hemolyzed and the fse replaced the valve, syringe, as well as the valve, manifold kit. No product deficiency or systemic issue was identified for the architect i2000sr and valve, syringe.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2017-00023 |
| MDR Report Key | 6298609 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-02-02 |
| Date of Report | 2017-04-24 |
| Date of Event | 2016-12-24 |
| Date Mfgr Received | 2017-03-29 |
| Date Added to Maude | 2017-02-02 |
| 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 | LKQ |
| Date Received | 2017-02-02 |
| Catalog Number | 03M74-02 |
| 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 |
| Brand Name | ARCHITECT I2000SR ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-02-02 |
| Catalog Number | 03M74-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-02-02 |