MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-08-28 for COBAS INTEGRA 800 I800 28122474001 manufactured by Roche Diagnostics.
[86165889]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86165890]
The customer received nineteen questionable patient results for rf-ii rheumatoid factors ii on (b)(6) 2017. The initial results were reported outside of the laboratory. The customer had to send out corrected reports for nineteen patients. Of the data provided, fifteen patient samples had discrepant results. Please see the attachment to this medwatch for relevant discrepant patient data. The repeat data was deemed to be correct. At this time there is no information to reasonably suggest that there was any adverse event. The information has been requested but has yet to be received from the customer. The rf-ii rheumatoid factors ii reagent lot number and expiration were ask for but not provided. The customer found a reagent probe that was loose and was leaking onto the reagent cassette area. The customer tightened the probe fitting and believes the issue has been resolved. The field engineering specialist was dispatched and found no other issues with the analyzer. He performed a check test, optics check, a workstation accuracy check, and a rf-ii rheumatoid factors ii precision run all which passed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01828 |
| MDR Report Key | 6823472 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-28 |
| Date of Report | 2017-09-21 |
| Date of Event | 2017-07-25 |
| Date Mfgr Received | 2017-08-08 |
| Date Added to Maude | 2017-08-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INTEGRA 800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DHR |
| Date Received | 2017-08-28 |
| Model Number | I800 |
| Catalog Number | 28122474001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS INTEGRA 800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-28 |
| Model Number | I800 |
| Catalog Number | 28122474001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-28 |