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 2020-02-20 for ACCU-CHEK ? FASTCLIX manufactured by Roche Diabetes Care, Inc..
[180167113]
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. Product is not expected to be returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[180167154]
It was reported that the lancet protrudes beyond the end cap of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011393376-2020-00672 |
| MDR Report Key | 9732455 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-02-20 |
| 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 | 2020-02-20 |
| Lot Number | ASKU |
| 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 | 2020-02-20 |