MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2015-07-13 for ARCHITECT I2000SR ANALYZER 03M74-02 manufactured by Abbott Manufacturing Inc.
[6032538]
The account stated one patient generated inconsistent cyclosporine results when processed on the architect i2000sr analyzer. A 9:00am draw time sample generated an architect cyclosporine result of 231 ng/ml which was questioned by the physician. The sample was rerun with architect cyclosporine results of 116, 117 and 159 ng/ml. The specimen was repeated at another lab with cyclosporine of 118 ng/ml. A 1:00pm draw time sample from the same patient generated an architect cyclosporine of 356 ng/ml, but reference lab result of 254 ng/ml. The reference lab result of 254 ng/ml was reported out of the laboratory. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[14209360]
(b)(4). A followup report will be submitted when the evaluation is complete. Evaluation in process.
Patient Sequence No: 1, Text Type: N, H10
[28485857]
Sample rerun result of 117 ng/ml was not generated by the account and was a typographical error. A field service representative replaced the r1 pipettor and calibrated the sample, r1, and r2 probes. The service history for this instrument revealed no subsequent complaints of discrepant/erratic results were reported. A review of similar complaints for erratic results did not identify an adverse trend of the probe or i2000sr analyzer. The architect system operations manual addresses troubleshooting of the described issue and the cyclosporine package insert addresses sampling handling and performance characteristics. A single definitive cause was not identified. An issue with sample handling/integrity could not be ruled out as the issue was isolated to a single patient sample tested. The field service representative calibrated the sample, r1, and r2 probes to resolve the result issue. The architect i2000sr analyzer is performing acceptably.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2015-00200 |
| MDR Report Key | 4911101 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2015-07-13 |
| Date of Report | 2015-09-10 |
| Date of Event | 2015-06-16 |
| Date Mfgr Received | 2015-08-28 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2015-07-21 |
| 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 | LTB |
| Date Received | 2015-07-13 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-13 |