MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-17 for QUATTRO PREMIER M946430DC1 manufactured by Waters Corporation.
[34589823]
A manufacturer investigation is in progress, and the results will be included in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[34589824]
It was reported to waters corporation that the laboratory had been experiencing some variable metadrenaline (met) responses with spurious peaks, and that an initial positive plasma test result indicating the presence of a pheochromocytoma tumor was submitted to the patient's physician on (b)(6) 2015. This test was part of a routine, ongoing process to monitor the patient for the potential recurrence of a tumor that was treated in 2013. As a consequence of the positive met result, the physician reportedly prescribed alpha and beta blockers and ordered a patient body scan (type unknown) in preparation for possible surgery to remove the suspected recurrent tumor. Subsequently, a confirmatory plasma met test for the patient was performed in (b)(6), and this time the result was negative. The body scan was also done during this time period, and the laboratory initially reported to waters that this was also negative for a tumor. However, the laboratory later indicated they had learned from the hospital where the scan was performed that it--or possibly an additional scan--may actually have been marginal or positive for a tumor. There is no direct access to the patient's physician or medical records, and it is currently unknown whether there has been a recurrence of the tumor. There has been no reported injury to the patient as a result of the positive plasma met result provided to the physician. The laboratory advised that the patient is at home and continuing the alpha and beta blocker medication regimen of phenoxybenzamine, 10 mg. Tds and propanolol, 20 mg. Bd. A third plasma met test will be performed with a new sample from the patient, and surgery is on hold pending the results and further investigation to obtain a more definitive diagnosis. Following this event, the laboratory indicated that they have suspended the use of this system for ivd applications. The laboratory continues to use its own ldt for metadrenaline. There have been no reports of any other patients being affected by suspected or confirmed incorrect results obtained using this system.
Patient Sequence No: 1, Text Type: D, B5
[60917200]
The customer indicated that no further information regarding the patient is available. The results of any additional testing performed to obtain a definitive diagnosis concerning the possible recurrence of a pheochromocytoma tumor are unknown. Waters field engineers performed an extended investigation which included ongoing system performance monitoring, on-site equipment testing and maintenance, and troubleshooting with laboratory staff at the user facility. The investigation determined that the instrument was operating according to specifications. Injection reproducibility was demonstrated, and the alleged issue of random, abnormally high plasma metadrenaline responses could not be reproduced using either customer samples or waters test material. Several observations were made consistent with cross-contamination of the customer mobile phase by the compounds being measured. The cause for the reported event could not be definitively traced, but was likely related to issues with the operation of the assay, apparently resolved by increased customer vigilance and care, or by some change in reagents or material used in sample preparation not captured by the investigation. The complainant stated that a sample mix-up could have occurred, but none of the original patient sample from (b)(6) 2015 remained for comparison testing to help support or eliminate this possibility. Some replacement parts have been changed as a precaution, although instrument testing did not indicate that this was necessary. The customer has dedicated the instrument to the plasma metadrenaline assay, which simplifies things operationally in terms of not having to switch between interfering methods. The customer has also changed the laboratory staff responsible for the assay. The instrument is back in use with no further similar incidents reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616673-2015-00001 |
| MDR Report Key | 5308082 |
| Date Received | 2015-12-17 |
| Date of Report | 2016-10-10 |
| Date of Event | 2015-10-26 |
| Date Mfgr Received | 2016-10-10 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2015-12-17 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JULIE ACKER |
| Manufacturer Street | 34 MAPLE ST. |
| Manufacturer City | MILFORD MA 017573696 |
| Manufacturer Country | US |
| Manufacturer Postal | 017573696 |
| Manufacturer Phone | 5084824061 |
| Manufacturer G1 | WATERS TECHNOLOGIES IRELAND, LTD. |
| Manufacturer Street | WEXFORD BUSINESS PARK |
| Manufacturer City | DRINAGH, WEXFORD, WEXFORD |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUATTRO PREMIER |
| Generic Name | MASS SPECTROMETER, CLINICAL USE |
| Product Code | DOP |
| Date Received | 2015-12-17 |
| Model Number | M946430DC1 |
| Operator | BIOMEDICAL ENGINEER |
| 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 | 34 MAPLE ST. MILFORD MA 017573696 US 017573696 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-17 |