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 2020-03-17 for ACCU-CHEK ? FASTCLIX manufactured by Roche Diabetes Care, Inc..
[183887168]
The event occurred outside of the united states. While this product is not sold in the united states, it is like or similar to a product marketed in the united states.
Patient Sequence No: 1, Text Type: N, H10
[183887169]
It was reported that the lancet protrudes beyond the end cap of the device. Customer accidentally pricked herself on the protruding lancet. No medical attention needed, could help herself.
Patient Sequence No: 1, Text Type: D, B5
[187655819]
The year is the only known part of manufacture date. We have defaulted to the first of the year.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3011393376-2020-00979 |
| MDR Report Key | 9846008 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-17 |
| 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 | NA GREG SMITH |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 462500457 |
| Manufacturer Country | US |
| Manufacturer Postal | 462500457 |
| Manufacturer Phone | 3175212484 |
| Manufacturer G1 | GERRESHEIMER REGENSBURG GMBH |
| Manufacturer Street | HIRTENSTRASSE 50 NA |
| Manufacturer City | PFREIMD 92536 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 92536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCU-CHEK ? FASTCLIX |
| Generic Name | LANCET DEVICE |
| Product Code | FMK |
| Date Received | 2020-03-17 |
| Lot Number | WPD049B |
| Device Expiration Date | 2019-07-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NULL |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIABETES CARE, INC. |
| Manufacturer Address | 9115 HAGUE ROAD INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |