MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-04-15 for WATERS TQD WITH MASSLYNX SOFTWARE TDQ 186003875 manufactured by Waters Corporation.
[1947837]
This (b)(6) laboratory customer reported results of pt samples (analyte benzodiazepines concentration assay) indicating a higher analyte concentration than the results calculated by waters' mass spectrometry software, targetlynx. The reported results were exported from (b)(6) to the customer's laboratory information management system (lims). Consequently, incorrect results (false positives) for fourteen (14) pts were reported by this laboratory to its customers. The laboratory subsequently identified the discrepancy and reported the correct results to its customers within twenty-four (24) hours. Repeated attempts by waters to gather information related to any pt impact from incorrect results being reported have been unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
[9043982]
The investigation into this issue indicated the laboratory had downgraded its (b)(6) software to a version that requires manual verification of data exported to a lims. The laboratory failed to execute its required manual verification of exported data. The customer subsequently performed a manual check of the (b)(6) data file for the affected pt samples and confirmed the results were accurately reported by (b)(6) and that these values differed after xml exportation to its lims. The customer also started that a review of historical data was performed and no other incidents of this error were identified. Should additional information become available, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616673-2011-00002 |
| MDR Report Key | 2074577 |
| Report Source | 06 |
| Date Received | 2011-04-15 |
| Date of Report | 2011-04-15 |
| Date of Event | 2010-06-15 |
| Date Mfgr Received | 2010-06-15 |
| Device Manufacturer Date | 2008-11-01 |
| Date Added to Maude | 2011-05-10 |
| 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 | KATHLEEN MORAHAN |
| Manufacturer Street | 34 MAPLE STREET |
| Manufacturer City | MILFORD MA 01757 |
| Manufacturer Country | US |
| Manufacturer Postal | 01757 |
| Manufacturer Phone | 5084823574 |
| 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 TQD WITH MASSLYNX SOFTWARE |
| Generic Name | MASS SPECTROMETER FOR CLINICAL USE (DOP) |
| Product Code | DOP |
| Date Received | 2011-04-15 |
| Model Number | TDQ |
| Catalog Number | 186003875 |
| Lot Number | NA |
| ID 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 CORPORATION |
| Manufacturer Address | MILFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-15 |