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 2017-08-10 for COBAS 8000 C 702 MODULE C702 06473245001 manufactured by Roche Diagnostics.
[83750323]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83750324]
The customer stated that they received erroneous results for three patient samples tested for hdlc3 hdl-cholesterol plus 3rd generation (hdl) on a cobas 8000 c 702 module (c702). The erroneous initial results were reported outside of the laboratory to the doctor. The samples were repeated on an unknown analyzer and the repeat results were believed to be correct. The first sample initially resulted as 9 mg/dl and repeated as 46 mg/dl. The second sample initially resulted as 13 mg/dl and repeated as 49 mg/dl on (b)(6) 2017. The third sample initially resulted as 7 mg/dl and repeated as 39 mg/dl on (b)(6) 2017. No adverse events were alleged to have occurred with the patients. The hdl reagent lot number was 16307001, with an expiration date of 04/30/2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01668 |
| MDR Report Key | 6784030 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-10 |
| Date of Report | 2017-09-05 |
| Date of Event | 2017-07-14 |
| Date Mfgr Received | 2017-07-21 |
| Date Added to Maude | 2017-08-10 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 8000 C 702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LBS |
| Date Received | 2017-08-10 |
| Model Number | C702 |
| Catalog Number | 06473245001 |
| 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 8000 C 702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-10 |
| Model Number | C702 |
| Catalog Number | 06473245001 |
| 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 | 2017-08-10 |