MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-07-14 for 07494190001 790-4905 manufactured by Ventana Medical Systems Inc.
[80081933]
Customer reported an erroneous test result when compared to the results from another institution utilizing an ldt (lab developed test). The patient sample which was diagnosed as 1% positive at the customer site and was diagnosed as 60% positive at the second site utilizing the ldt. No patient specific information has been provided at this time. It is unknown what diagnosis was made and what treatment given. Potentially a change in treatment options would result for a 1% positive test result versus a 60% positive test result.
Patient Sequence No: 1, Text Type: N, H10
[80081934]
Customer reported an erroneous test result when compared to the results from another institution utilizing an ldt (lab developed test). The patient sample which was diagnosed as 1% positive at the customer site and was diagnosed as 60% positive at the second site utilizing the ldt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2017-00003 |
| MDR Report Key | 6715098 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-14 |
| Date of Report | 2017-07-14 |
| Date of Event | 2017-06-14 |
| Date Mfgr Received | 2017-06-14 |
| Device Manufacturer Date | 2016-06-22 |
| Date Added to Maude | 2017-07-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | NA TIM GIBLIN |
| Manufacturer Street | 1910 EAST INNOVATION PARK DR NA |
| Manufacturer City | TUSCON AZ 85755 |
| Manufacturer Country | US |
| Manufacturer Postal | 85755 |
| Manufacturer Phone | 5208777035 |
| Manufacturer G1 | VENTANA MEDICAL SYSTEMS INC |
| Manufacturer Street | 1910 E INNOVATION PARK DR NONE |
| Manufacturer City | TUCSON AZ 857551962 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 857551962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PD-L1 SP263 |
| Product Code | PLS |
| Date Received | 2017-07-14 |
| Model Number | 07494190001 |
| Catalog Number | 790-4905 |
| Lot Number | G04791 |
| ID Number | UDI# 04015630976928 |
| Device Expiration Date | 2018-06-28 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTANA MEDICAL SYSTEMS INC |
| Manufacturer Address | 1910 E INNOVATION PARK DR NA TUCSON AZ 857551962 US 857551962 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-14 |