MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-08-10 for WATERS QUATTRO MICRO VB-QMICRO manufactured by Waters Corp..
[2165622]
The customer reported that while running immunosuppressant assays on a mass spectrometer, they entered a sample list file that had errors. After the run was started, the customer corrected the errors on the sample list, but did not restart the batch run as required. Subsequently, incorrect results were reported to physicians. As reported by the customer, one physician contacted the lab and questioned the results. This physician did not use the results for diagnostic purposes. The customer re-ran all the samples tested in the suspect batch, and submitted corrected results to all affected physicians within three or four hrs after the incorrect results were reported. The customer has not received any reports of adverse pt health consequences as a result of this issue.
Patient Sequence No: 1, Text Type: D, B5
[9405265]
The investigation of the event by waters' technical support and the customer determined that the incorrect results were caused by alterations made to the sample list during the run of immunosuppressant sample set using masslynx software. The customer requested and received clarification from waters on how to correctly alter a sample list during the run. Further review of the issue by a waters (b)(4) and a waters (b)(4) determined that the masslynx software operated as designed. Appropriate f/u action will be taken if required. If additional info becomes available, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616673-2011-00003 |
| MDR Report Key | 2222864 |
| Report Source | 05,06 |
| Date Received | 2011-08-10 |
| Date of Report | 2011-08-09 |
| Date of Event | 2011-07-20 |
| Date Mfgr Received | 2011-07-25 |
| Date Added to Maude | 2011-10-03 |
| 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 G1 | WATERS 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 | WATERS QUATTRO MICRO |
| Generic Name | MASS SPECTROMETER FOR CLINICAL USE (DOP) |
| Product Code | DOP |
| Date Received | 2011-08-10 |
| Model Number | QUATTRO MICRO |
| Catalog Number | VB-QMICRO |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATERS CORP. |
| Manufacturer Address | MILFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-10 |