MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2009-09-21 for ARCHITECT I2000SR ANALYZER 3M74-95 manufactured by Abbott Manufacturing, Inc..
[1149122]
The customer states that patient samples processed using the architect cmv igm assay are generating falsely positive results. The customer states that results are negative when samples are sent out of the lab for confirmation testing. No specific patient data was provided. No adverse outcomes were reported related to this issue.
Patient Sequence No: 1, Text Type: D, B5
[8314393]
(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
[8406182]
(b)(4). Other (b)(4): erratic cytomegalovirus (cmv) igg, (b)(6), and rubella igg results. Investigation plan summary: a review of the complaint text indicates the customer observed rubella igg and (b)(6) controls failing. The customer is also experiencing low reactive cytomegalovirus (cmv) igg patient results that are retested negative when sent for confirmation. Even after replacing the sample probe, the issue persisted. The customer also noticed excessive crystal build up around the sample probe wash cup, which continuously returned after cleaning the area. The field service engineer (fse) installed technical service bulletin (tsb) (b)(4) architect software v5. 10 installation onto the analyzer on (b)(6) 2009. He replaced and calibrated the reagent 1, reagent 2, and sample probes. The fse removed the syringes to check and clean all the pipettor and tubing connections. No leaks were observed in the pump bay area. He tightened all of the wash zone, pretrigger, trigger valves. The wash zone 1 and 2 aspiration, optics background, trigger, and pretrigger gravimetric tests were performed. All these tests passed specifications. The quality control values were within acceptable ranges. No sample carryover issues were observed during the carryover study. The precision of rubella igg, (b)(6), and cmv igm were within normal ranges. Review of complaint metrics identified no adverse trends in conjunction with the complaint issue currently under evaluation. Based on the available information, no deficiency identified for this complaint. A malfunction of the system was not identified. After the field service engineer performed a multipoint instrument check and troubleshooting of the instrument, the customer issue has not reoccurred, the instrument has been performing as intended. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2009-00443 |
| MDR Report Key | 1477076 |
| Report Source | 01 |
| Date Received | 2009-09-21 |
| Date of Report | 2009-09-11 |
| Date of Event | 2009-09-11 |
| Date Mfgr Received | 2009-10-20 |
| Device Manufacturer Date | 2006-01-17 |
| 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 |
| 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 | OMI |
| Date Received | 2009-09-21 |
| Catalog Number | 3M74-95 |
| Operator | OTHER |
| 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 | 2009-09-21 |