MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-06 for XEVO TQ MASS SPECTROMETER 186004490 manufactured by Waters Corp..
[2216416]
A (b)(4) hosp customer utilizing a xevo tq mass spectrometer reported cyclosporine a (cya) results to physicians that were subsequently determined to be below the pass/fail criteria of an international proficiency testing (ipt) scheme. The customer is still evaluating if there was any pt impact.
Patient Sequence No: 1, Text Type: D, B5
[9432978]
On the same day the low cya results were received by the hosp a (b)(4) service engineer was on site working on this specific instrument to resolve an unrelated issue with respect to another method under development. The instrument underwent repairs to address the unrelated issue making subsequent assessment of the instrument in a pre-repaired condition impossible. Therefore, it is not known if the condition of the instrument prior to the repairs contributed to the low cya results. The instrument is still under eval. The customer was also using a waters masstrak xe ruo reagent kit. At this time, it does not appear that the kit caused or contributed to the low cya results. Should add'l info become available, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616673-2011-00004 |
| MDR Report Key | 2288350 |
| Report Source | 05,06 |
| Date Received | 2011-10-06 |
| Date of Report | 2011-10-06 |
| Date of Event | 2011-08-16 |
| Date Mfgr Received | 2011-08-31 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2011-10-14 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHLEEN MORAHAN |
| Manufacturer Street | 34 MAPLE ST. |
| Manufacturer City | MILFORD MA 01757 |
| Manufacturer Country | US |
| Manufacturer Postal | 01757 |
| Manufacturer Phone | 5084823574 |
| Manufacturer G1 | WEXFORD TECHNOLOGIES IRELAND, LTD. |
| Manufacturer Street | WEXFORD BUSINESS PARK, DRINAGH |
| Manufacturer City | WEXFORD |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XEVO TQ MASS SPECTROMETER |
| Generic Name | MASS SPECTROMETER FOR CLINICAL USE (DOP) |
| Product Code | DOP |
| Date Received | 2011-10-06 |
| Model Number | XEVO TQ |
| Catalog Number | 186004490 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATERS CORP. |
| Manufacturer Address | MILFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-06 |