MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-23 for ACCU-CHEK ? FASTCLIX 05864666160 manufactured by Roche Diabetes Care, Inc..
[184452458]
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
[184452459]
It was reported that the lancet protrudes beyond the end cap of the device.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3011393376-2020-01100 |
MDR Report Key | 9864999 |
Report Source | CONSUMER |
Date Received | 2020-03-23 |
Date of Report | 2020-03-23 |
Date of Event | 2020-02-17 |
Date Mfgr Received | 2020-02-27 |
Device Manufacturer Date | 2018-01-01 |
Date Added to Maude | 2020-03-23 |
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 | BALDA MEDICAL GMBH & CO. KG |
Manufacturer Street | BERGKICHENER STR. 228 NA |
Manufacturer City | BAD OEYNHAUSEN 32549 |
Manufacturer Country | GM |
Manufacturer Postal Code | 32549 |
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 | 2020-03-23 |
Catalog Number | 05864666160 |
Lot Number | 33318172 |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Age | NULL |
Device Eval'ed by Mfgr | N |
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 | 2020-03-23 |