MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-04-05 for BD PREPSTAIN 05CR000021 manufactured by Tripath Imaging, Inc..
[19015388]
The customer contacted technical support via telephone that the prepstain ag was not properly transferring specimens. The initial complaint ((b)(4)) noted, "(b)(6), ct supervisor, had a ct report to her that she noticed a pattern of 3 sets of 4 slides in a row that were identical about a week ago. This was the 4th tray on a run of 48. Slides 1, 2, 3, 4 were the same case from centrifuge tube 1. Slides 5, 6, 7, 8 were the same case from tube 5. Slides 9, 10, 11, 12 were the same case from centrifuge tube 9. The first 3 trays on the same run were fine. They reprocessed these 12 cases from tray 4 and while cases 1, 5 and 9 matched the first run, all other cases were different. They reviewed several runs before and after this incident and did not find this situation duplicated but are concerned and would like the instrument checked out. " the customer followed up via telephone the same day in call (b)(6) indicating "that upon further testing they have observed the instrument on a test run and that tray 4 is reproducibly miss transferring specimens. Based on this it has been 6 days that they know of that this instrument has been miss transferring specimens. They run 5-11 runs per day on this instrument. "
Patient Sequence No: 1, Text Type: D, B5
[19059600]
The incident did not lead to death or serious deterioration in the health of a patient or user; however, information does suggest that if the device malfunction were to recur, it would contribute to an incorrect diagnosis. A total of 258 patient samples were impacted. All samples were re-tested resulting in one amended report for a (b)(6). A bd field service engineer was dispatched to the customer site. Bd confirmed the tube rack settings on rack 4 only was incorrect due to human error. The prepstain rack settings were corrected and the system was verified as operational. Bd investigation (b)(4) was opened to identify root cause and corrective action.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1062336-2013-00005 |
| MDR Report Key | 3050262 |
| Report Source | 05,06 |
| Date Received | 2013-04-05 |
| Date of Report | 2013-03-08 |
| Device Manufacturer Date | 2003-09-01 |
| Date Added to Maude | 2013-06-05 |
| 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 | STEVE BINION, DIRECTOR |
| Manufacturer Street | 4025 STIRRUP CREEK DR. STE 400 |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9192067158 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD PREPSTAIN |
| Generic Name | PREPSTAIN AG |
| Product Code | MNM |
| Date Received | 2013-04-05 |
| Catalog Number | 05CR000021 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRIPATH IMAGING, INC. |
| Manufacturer Address | 780 PLANTATION DR. BURLINGTON NC 27215 US 27215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-05 |