MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2009-12-23 for ARCHITECT I2000 ANALYZER 3M74-01 manufactured by Abbott Manufacturing, Inc..
[8449176]
(b)(4). Other (b)(4): the customer performed troubleshooting with the help of the abbott technical support officer (tso). The customer cleaned the wash zones due to salt deposits. Several gravimetric tests were performed and the customer indicated that the results were acceptable. An abbott field service representative (fsr) was dispatched due to liquid leaking from the analyzer. The fsr repaired the leak and reported the analyzer was performing according to specifications. Subsequently as a result of technical evaluations not related to this complaint issue, the architect analyzer (b)(4) was de-installed from the customer site. The customer received a replacement analyzer, (b)(4). In addition customer complaint data was reviewed and no adverse trends were identified. The architect system operations manual and the architect (b)(4) assay package insert were reviewed and were found to adequately address the issue of erratic results. The investigation did not identify a product deficiency. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
[18840559]
The account stated that the architect analyzer generated an initial negative (b)(6) result of s/co=0. 815 on a donor sample. The sample was repeated because the result was higher than the average read of donors. The sample was repeated on another analyzer with (b)(6) results of 1. 168 (plasma buffy sample) and 1. 173 (centrifuged serum sample). The same reagent lot number was used on both analyzers. The negative results were not reported. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[19120661]
(b)(4). This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2009-00781 |
| MDR Report Key | 1563664 |
| Report Source | 01 |
| Date Received | 2009-12-23 |
| Date of Report | 2009-11-30 |
| Date Mfgr Received | 2010-02-16 |
| Device Manufacturer Date | 2004-11-12 |
| Date Added to Maude | 2010-02-26 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 I2000 ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | NHS |
| Date Received | 2009-12-23 |
| Catalog Number | 3M74-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2009-12-23 |