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 2017-05-31 for COBAS 8000 C 702 MODULE C702 06473245001 manufactured by Roche Diagnostics.
[76317440]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76317441]
The customer received a questionable bilt3 bilirubin total gen. 3 result for one patient sample. The initial result was 9. 6 mg/dl. The repeat result with a 1:3 dilution was 13. 47 mg/dl. The erroneous initial result was reported outside the laboratory. The repeat result was believed to be correct. There was no adverse event. The reagent lot number was 18673301 with an expiration date of 04/30/2018. The field service representative found the gear pump pressure was low which he adjusted to specification. He performed checks of the probe alignments, the rinse tubings, and cuvette water levels which were ok. He ran a mechanism check with no problem found. He ran precision testing and results were all within specification. The customer ran qc and verified results were within their specification. A query found no past or new complaints of this nature on a like instrument at this site during the past 12 months. No abnormal trend identified with the pump head assembly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01115 |
| MDR Report Key | 6601392 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-31 |
| Date of Report | 2017-05-31 |
| Date of Event | 2017-05-15 |
| Date Mfgr Received | 2017-05-15 |
| Date Added to Maude | 2017-05-31 |
| 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 | MQM |
| Date Received | 2017-05-31 |
| Model Number | C702 |
| Catalog Number | 06473245001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-05-31 |
| Model Number | C702 |
| Catalog Number | 06473245001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-05-31 |