MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-08-02 for ARCHITECT I2000SR ANALYZER 03M74-01 manufactured by Abbott Manufacturing Inc.
[2736484]
The customer stated that they had at least 3 patients with false positive cmv igg results generated by the architect i2000 analyzer. The results were negative with another technique and when repeated a third time on the architect they were negative. The customer reported the negative results. No specific data was provided by the customer. There was no report of impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[10091613]
(b)(4). 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
[10100809]
A field service representative (fsr) replaced and calibrated three wash zone needles. He also observed a leaking trigger pump which was replaced. In a subsequent visit, the sample, r1, and r2 probes were replaced to resolve the customer issue. The customer recentrifuged the patient samples and repeated testing. Negative results were confirmed and reported. Probe replacement resolved the issue. Customer complaint data was reviewed and no adverse trends were identified related to the customer issue. The architect cmv igg reagent package insert and the architect system operations manual were reviewed and were found to adequately address the issue. The investigation did not identify a product deficiency.
Patient Sequence No: 1, Text Type: N, H10
[26392560]
A correction to manufacture name, city and state was made as it was missing in the followup-01 report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2012-00355 |
| MDR Report Key | 2679222 |
| Report Source | 01,05 |
| Date Received | 2012-08-02 |
| Date of Report | 2012-07-09 |
| Date Mfgr Received | 2013-09-23 |
| Device Manufacturer Date | 2006-01-31 |
| Date Added to Maude | 2012-11-14 |
| 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 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 | 847937-512 |
| 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 |
| Product Code | OMI |
| Date Received | 2012-08-02 |
| Catalog Number | 03M74-01 |
| Operator | OTHER |
| 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 | 2012-08-02 |