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 2017-08-16 for COBAS 8000 C 702 MODULE C702 06473245001 manufactured by Roche Diagnostics.
[83313834]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83313835]
The customer stated that they received an erroneous result for one patient sample tested for hdlc3 hdl-cholesterol plus 3rd generation (hdl) on a cobas 8000 c 702 module (c702). The erroneous result was not reported outside of the laboratory. The customer states that the field service engineer has been on site multiple times for the same issue. An aliquot sample processed on a modular pre-analytics system and tested on the c702 analyzer initially resulted as 10 mg/dl. The primary tube of the sample was repeated on a different c702 analyzer, resulting as 91 mg/dl. The patient was not adversely affected. The hdl reagent lot number was 16307001, with an expiration date of 04/30/2018. The field service engineer could not determine a cause. He replaced the degasser and reagent probes. He performed alignments. The customer successfully ran calibration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01702 |
| MDR Report Key | 6796644 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-16 |
| Date of Report | 2017-09-01 |
| Date of Event | 2017-07-26 |
| Date Mfgr Received | 2017-07-26 |
| Date Added to Maude | 2017-08-16 |
| 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 | 2017-08-16 |
| 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 | 2017-08-16 |
| 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 | 2017-08-16 |