MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2017-11-30 for THINPREP IMAGING SYSTEM 70564-001 manufactured by Hologic Inc..
[93305089]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[93305090]
The customer reported autoloader t5000, "vial is picked up, it's uncap, and then, instead of doing the sipping and cell spot effectively, the vial is thrown away. Customer reported that already 1 patient sample has been lost. Customer is afraid of losing more samples, so she has switched off the instrument. " hologic field service engineer (fse) went to the customer cleared broken slide and dust from base of lift and spin assembly. Re-taught scars to input carousel setups. Fse confirmed and reproduced error. Instrument operational.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2017-00278 |
| MDR Report Key | 7070229 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| 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 | 70564-001 |
| 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 | 1. Other | 2017-11-30 |