MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-11-12 for TOSOH AIA 360 AIA 360 STANDARD 019945 manufactured by Tosoh Hi-tec Inc..
[1741438]
A tosoh trained field service engineer (fse) was on site at (b)(6) medical center, (b)(6) on (b)(6) 2010. The fse cleaned the aia 360 unit (b)(4) which was not properly maintained. The customer discussed qc being out of range for troponin cardiac marker. The fse noted on reviewing their qc data that they had repeatedly released pt results with two or more levels of qc being out of range over the past few months. The fse pressed the importance of qc being in range prior to releasing any results. An alternative control was run for troubleshooting purposes post fse instrument service, and it performed close to the mean. The fse reports that the customer's bio-rad qc material was running higher than the peer group. This was viewed as a positive event and grounds for releasing pt results when qc was out of range. The control results were out of range due to lack of proper maintenance. Pt results could be suspect for the same reason, however, no report was made of questionable results.
Patient Sequence No: 1, Text Type: D, B5
[8974589]
The device indicated that there was a systemic problem which was ignored by the customer. The instrument was serviced and certified to be performing to specifications, the device is used for diagnostic (and not treatment) purposes. On nov 12th, (b)(4) of tosoh bioscience sent a letter with delivery confirmation to (b)(6) outlining the importance of performing routine maintenance as outlined in the aia-360 operator's manual. Also sent was a regulatory compliance cd which contains info on the latest clia guidelines available online at http://www. Cms. Gov/clia/. The clinical laboratory improvement amendments of 1988 (clia) established quality standards for all lab testing to ensure the accuracy, reliability and timeliness of pt test results regardless of where the test is performed. Useful links are available on topics such as: verification of performance specifications, calibration and calibration verification, equivalent quality control procedures, laboratory director responsibilities.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005529799-2010-00010 |
| MDR Report Key | 1901607 |
| Report Source | 07 |
| Date Received | 2010-11-12 |
| Date of Report | 2010-11-12 |
| Date of Event | 2010-11-08 |
| Date Facility Aware | 2010-11-08 |
| Report Date | 2010-11-12 |
| Date Reported to FDA | 2010-11-12 |
| Date Mfgr Received | 2010-11-08 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2010-11-17 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOHN MURPHY |
| Manufacturer Street | 6000 SHORELINE CT, STE 101 |
| Manufacturer City | SOUTH SAN FRANCISCO CA 94080 |
| Manufacturer Country | US |
| Manufacturer Postal | 94080 |
| Manufacturer Phone | 6506368143 |
| Manufacturer G1 | TOSOH HI-TEC, INC. |
| Manufacturer Street | 1-37 FUKUGAWA MINAMO MACHI SHUNAN-SHI |
| Manufacturer City | YAMAGUCHI, YAMAGUTI 746-0042 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 746-0042 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOSOH AIA 360 |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | OMI |
| Date Received | 2010-11-12 |
| Model Number | AIA 360 STANDARD |
| Catalog Number | 019945 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOSOH HI-TEC INC. |
| Manufacturer Address | 1-37 FUKUGAWA MINAMO MACHI SHUNAN-SHI YAMAGUCHI, YAMAGUTI 746-0042 JA 746-0042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-12 |