MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2017-11-30 for THINPREP IMAGING SYSTEM 71362-001 manufactured by Hologic Inc..
[93428503]
Internal complaint reference# (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[93428504]
The customer reported we are experiencing a label reader issue with the t-5000 since ap order entry/accessioning was advised by a hologic fse to raise the placement of the label so as to reduce label ripping/tearing on the tomcat. This new higher placement of labels on the thinprep vials has affected the sweet spot of the label reader on the t-5000s which in turn has elicited more vial/slide mismatch errors. Fse dispatched. C. - label misreads due to labels being adjusted up on vials. E - fse aj ribic had accessioning move labels due to issues with the tc, r - adjusted vial readers on the t5 to compensate new label position, t - ran go no go and verified labels correctly read.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2017-00277 |
| MDR Report Key | 7072480 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2017-11-30 |
| Date of Report | 2017-10-31 |
| Date of Event | 2017-10-31 |
| Date Mfgr Received | 2017-10-31 |
| Date Added to Maude | 2017-11-30 |
| 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 | 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 |
| Manufacturer Phone | 5082638884 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THINPREP IMAGING SYSTEM |
| Generic Name | AUTOMATED MICROSCOPE FOR CYTOLOGY |
| Product Code | MNM |
| Date Received | 2017-11-30 |
| Model Number | 71362-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-11-30 |