MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-01-27 for THINPREP 2000 PROCESSOR manufactured by Hologic, Inc.
[65909026]
Unique identifier (udi): this unit was built before the udi was required so there isn't one available for it. Device history record (dhr) review was conducted for the reported identification number. The lot was released meeting all qa specifications. Internal reference complaint#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[65909027]
Customer reported error code se 06 00 on the instrument. The customer had this issue a few times the last few days. Customer also confirmed that they had to call back one customer because all the sample was lost. The customer ran a pneumatic test and it passed. Hologic field service engineer went on site confirmed and reproduced error. Replaced the following parts, 71950-001, 70035-001 and 04958-001 to resolve the error. Performed inspection, instrument operational. Although the instrument produced an error code during this incident, this is a reportable event since a patient needed to be recalled for additional sample collection, which resulted in a delay in patient diagnosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2017-00011 |
| MDR Report Key | 6282358 |
| Report Source | FOREIGN |
| Date Received | 2017-01-27 |
| Date of Report | 2016-12-30 |
| Date Mfgr Received | 2016-12-30 |
| Date Added to Maude | 2017-01-27 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS SIDRA PIRACHA |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THINPREP 2000 PROCESSOR |
| Generic Name | THINPREP 2000 PROCESSOR |
| Product Code | MKQ |
| Date Received | 2017-01-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-27 |