MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-06-14 for XEVO TQ-S 186005453IVD manufactured by Waters Corporation.
[3472825]
Based on the information provided by the customer: on (b)(6) 2013 the customer reported that the wrong peak was being selected in samples, resulting in incorrect results being reported. The customer performs opioid screening and pain management monitoring.
Patient Sequence No: 1, Text Type: D, B5
[10753111]
Based on the information provided, the reported inaccurate results were related to the customer's handling of the data, not an issue with the instrument or the results that were generated. A waters investigation into the issue found that no device failure had occurred. The customer had selected "update retention times" in the software, which automatically selects the largest peak in the trace when multiple peaks are present. The embedded help file for the instrument's software states, "when updating retention times, the retention time of the peak with the biggest area on the trace used by his compound is used to update the retention time in the method. If more than one compound uses the same trace, then the biggest peaks on a trace are assigned to compounds in the method in their relative retention time order. " based on the customer's method, multiple peaks would be expected in their trace. By selecting "update retention time," the customer set the software to select the largest peak in the trace, which in this case was not the customer's peak of interest. The instrument performed as expected. The issue was with the data selected by the customer, not the accuracy of the results generated by the instrument. No adverse patient reactions were reported and there is no indication that patient therapies were altered as a result of the reported results. Training regarding use of the instrument and its settings was provided to the customer. The customer confirmed that they have modified their data review procedure. We consider this report to be complete. However, if additional relevant information is reported, we will submit a supplemental mdr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616673-2013-00001 |
| MDR Report Key | 3181457 |
| Report Source | 06 |
| Date Received | 2013-06-14 |
| Date of Report | 2013-05-17 |
| Date of Event | 2013-05-17 |
| Date Mfgr Received | 2013-05-17 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2013-06-24 |
| 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 | MICHAEL PACHECO |
| Manufacturer Street | 34 MAPLE STREET |
| Manufacturer City | MILFORD MA 01757 |
| Manufacturer Country | US |
| Manufacturer Postal | 01757 |
| Manufacturer Phone | 5084822352 |
| Manufacturer G1 | WATERS TECHNOLOGIES IRELAND LTD |
| Manufacturer Street | WEXFORD BUSINESS PARK |
| Manufacturer City | DRINAGH, WEXFORD |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XEVO TQ-S |
| Generic Name | DOP MASS SPECTROMETER, CLINICAL USE |
| Product Code | DOP |
| Date Received | 2013-06-14 |
| Model Number | XEVO TQ-S |
| Catalog Number | 186005453IVD |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATERS CORPORATION |
| Manufacturer Address | 34 MAPLE STREET MILFORD MA 01757 US 01757 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-06-14 |