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 2017-05-17 for COBAS 8000 C 702 MODULE C702 06473245001 manufactured by Roche Diagnostics.
[75308395]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75308396]
The customer stated that they have had ongoing issues with questionable results for an unspecified number of patient samples tested for albp albumin bcp (alb) on a cobas 8000 c 702 module (c702). The customer provided an example of one patient sample that had an erroneous initial alb result that was reported outside of the laboratory. The sample initially resulted as 2. 1 g/dl. The sample was repeated on a different analyzer, resulting as 2. 8 g/dl. The repeat result was believed to be correct. The patient was not adversely affected. The alb reagent lot number was 219743. The reagent expiration date was asked for, but not provided. The laboratory room temperature and humidity were acceptable. No air bubbles were observed on the surface of the alb reagent when the cassette was loaded.
Patient Sequence No: 1, Text Type: D, B5
[79153884]
A specific root cause could not be determined based on the provided information. Additional information required for the investigation was requested, but not provided. The customer stated that the issue was solved by the following service actions: the field service engineer suspects that there is an environmental issue with the reagent compartment of the analyzer. He checked pump pressures and pipetting; no issues were identified. Alb is the only assay affected on rotor b of the analyzer. He states that values recover lower when 1/3 of the reagent is remaining. The issue is not resolved upon multiple calibration attempts and quality control runs. Controls run on a fresh uncalibrated reagent pack recover near the mean. Probe adjustments did not resolve the issue. The temperature within the reagent compartment was good. Considerable condensation was visible within rotor b. He replaced an air pump diaphragm since a hole was found. He ran precision studies, yielding excellent results. No imprecision or pipetting failure was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01017 |
| MDR Report Key | 6571612 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-17 |
| Date of Report | 2017-06-05 |
| Date of Event | 2017-04-23 |
| Date Mfgr Received | 2017-04-23 |
| Date Added to Maude | 2017-05-17 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CJW |
| Date Received | 2017-05-17 |
| 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 | 2017-05-17 |
| 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 | 2017-05-17 |