MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-07-15 for 2795 SEPARATIONS MODULE 186000264 manufactured by Waters Corporation.
[17960890]
Conclusions - the customer reported that they replaced a wet and leaking syringe on the instrument. This customer had also reported low internal standard injection response on the instrument. When the waters service engineer arrived at the lab to investigate the issue, he could not duplicate the low internal standard injection response. It is possible that the wet and leaking syringe could result in inconsistent volume that may affect internal standard response. Replacement of the syringe appears to have corrected the issue. Waters will file a supplemental report if add'l info becomes available.
Patient Sequence No: 1, Text Type: N, H10
[17975098]
This diagnostic laboratory customer reported two instances of low internal standard injection response that affected two reported pt results. In the first case, when the lab identified the error, the test was repeated. Since the difference in the reported test result was within the therapeutic range for the reported result, it was not corrected. In the second case, the lab reported that the inaccurate result was found weeks later. There was no physician request for a repeat test. Therefore, the lab did not take any further action. The sample has subsequently been discarded. Attempts to gain info on any pt impact in this case have been unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218959-2011-00001 |
| MDR Report Key | 2186910 |
| Report Source | 06 |
| Date Received | 2011-07-15 |
| Date of Report | 2011-07-15 |
| Date Mfgr Received | 2011-06-23 |
| Date Added to Maude | 2012-05-25 |
| 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 | WATERS CORPORATION |
| Manufacturer Street | 34 MAPLE ST. |
| Manufacturer City | MILFORD MA 01757 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01757 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2795 SEPARATIONS MODULE |
| Generic Name | HIGH PRESSURE LIQUID CHROMATOGRAPHY |
| Product Code | LDM |
| Date Received | 2011-07-15 |
| Model Number | 2795 |
| Catalog Number | 186000264 |
| Lot Number | NOT APPLICABLE |
| ID Number | EQUIPMENT #21158236 |
| 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 | 2011-07-15 |