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 2020-03-30 for ACCU-CHEK ? RAPIDLINK INFUSION SET manufactured by Roche Diabetes Care, Inc..
[185673823]
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. It was reported this issue only occurred with one lot/pack of infusion sets, however two different lot numbers ( 32134189 and 32174299) of infusion sets were logged on the case. Therefore, using the lot of asku, since we are unable to determine which lot produced the leak at this time.
Patient Sequence No: 1, Text Type: N, H10
[185673824]
It was reported that one pack of infusion sets was leaking at the headset. Lots 32134189 and 32174299 were reported. It is unknown which lot is alleged to have leaked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011393376-2020-01214 |
| MDR Report Key | 9898718 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-24 |
| Date Mfgr Received | 2020-03-24 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| 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 | FRESENIUS KABI DEUTSCHLAND GMBH |
| Manufacturer Street | ROBERT-KOCH-STRASSE 5 NA |
| Manufacturer City | BAD HERSFELD D-36251 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-36251 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCU-CHEK ? RAPIDLINK INFUSION SET |
| Generic Name | SUBCUTANEOUS INFUSION SET |
| Product Code | FPA |
| Date Received | 2020-03-30 |
| 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 | 2020-03-30 |