MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-02-03 for ARCHITECT I2000SR ANALYZER 3M74-01 manufactured by Abbott Manufacturing, Inc..
[1897418]
The customer states that a sample from a potential liver transplant patient with alcoholic liver disease generated a false positive architect cmv igg assay result of greater than 250 au/ml. The sample was retested multiple times and generated negative results of 2. 2, 2. 0, 2. 2 and 2. 4 au/ml. The sample was then tested by a non-abbott methodology and generated a negative cmv igg assay result. There was no impact to the decision as to whether or not the patient was transplant eligible or not. The sample for this patient was received in the lab and split into an aliquot tube. This aliquot tube was used for the initial testing. Subsequent retests were performed on the original (twice) and aliquot (twice) tubes. There is no further patient information available.
Patient Sequence No: 1, Text Type: D, B5
[8832238]
(b)(4). An abbott field service representative (fsr) replaced a leaking wash zone drain valve on the architect i2000sr analyzer. The fsr found and serviced a leak in the pump bay on the buffer sensor. The fsr found the dispersion gear support wheels seized, replaced the support wheels, and cleaned the reagent compartment. The fsr replaced a bent r2 probe, and calibrated the r1 and r2 pipettors. The fsr performed successful wash zone 1 and 2 aspiration tests, and a successful optics background test. The fsr performed a successful gravimetric test. The customer performed calibration and control runs, and all results were within expected ranges. The fsr documented the instrument was running to specification. The complaint text also notes that the integrity of the patient samples that generated the discrepant results may not have been verified. Sample integrity cannot be ruled out as a possible cause of the customer's issue. The architect system operations manual (revision 96211-112) and the cmv igg package insert ((b)(4)) both contain information to address the customer's current issue. A review of complaint tracking and trending metrics and service history records was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. Review of complaint tracking and trending; field service intervention.
Patient Sequence No: 1, Text Type: N, H10
[8936139]
(b)(4). An investigation is in process. A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2011-00060 |
| MDR Report Key | 1978103 |
| Report Source | 01 |
| Date Received | 2011-02-03 |
| Date of Report | 2011-01-26 |
| Date of Event | 2011-01-25 |
| Date Mfgr Received | 2011-03-03 |
| Device Manufacturer Date | 2006-09-05 |
| Date Added to Maude | 2012-01-13 |
| 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 | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| 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 | 2011-02-03 |
| 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 | 2011-02-03 |