MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-16 for COBAS 8800 SYSTEM 05412722001 manufactured by Stacie-ann Creighton.
[97953387]
The investigation into this issue is currently on-going. The outcome of this investigation will be communicated through a follow-up report. The udi for the cobas 8800 system is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[97953388]
A customer in (b)(6), reported that the cobas 8800 system stopped and went into an "error" state during a run as a processing tip remained attached to the sample transfer head due to a defect in the tip, which kept it stuck on the sample transfer head. As no error event was generated on the failed tip ejection, the stuck processing tip was re-used by the cobas 8800 system to pipette another sample from a different donor tube. When attempting to dispose this re-used processing tip, the cobas 8800 system went into an "error" state and the run was not completed. The re-use of a processing tip could potentially lead to contamination of a clinical specimen; however, no contamination event occurred at the customer site and there was no indication of harm or injury to any donor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2018-00001 |
| MDR Report Key | 7195239 |
| Date Received | 2018-01-16 |
| Date of Report | 2018-03-14 |
| Date of Event | 2017-12-12 |
| Date Mfgr Received | 2017-12-18 |
| Date Added to Maude | 2018-01-16 |
| 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 STACIE-ANN CREIGHTON |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537112 |
| Manufacturer G1 | ROCHE INTERNATIONAL ROTKREUZ |
| Manufacturer Street | FORRENSTRASSE 2 NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COBAS 8800 SYSTEM |
| Generic Name | AUTOMATED BLOODBORNE PATHOGEN TEST EQUIPMENT |
| Product Code | MZA |
| Date Received | 2018-01-16 |
| Model Number | NA |
| Catalog Number | 05412722001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STACIE-ANN CREIGHTON |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-16 |