MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-30 for COBAS 8000 C701 MODULE 05641489001 manufactured by Roche Diagnostics.
[17183944]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[17195555]
After noticing an issue with their proficiency survey results, the customer decided to run a ten patient comparison study for (b)(4). Of the ten samples, one was found to have an (b)(6) result. The sample initially resulted as 76 u/l and this value was reported outside of the laboratory. The sample was later pulled as part of the comparison study and sent to a sister site to run on their c501 analyzer, resulting as 45 u/l. The 45 u/l value was believed to be correct. The customer stated that both the initial and repeat values were within the normal range, so they did not correct the report. The patient was not adversely affected by the event. The ck reagent lot number was 65107101 with an expiration date of 07/31/2012. The customer declined a service visit. The customer suspected an issue with cells in the affected sample as it was cloudy.
Patient Sequence No: 1, Text Type: D, B5
[17352033]
A specific root cause could not be determined. Additional information was not provided for further investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-02894 |
| MDR Report Key | 2592583 |
| Report Source | 05,06 |
| Date Received | 2012-05-30 |
| Date of Report | 2012-07-03 |
| Date of Event | 2012-05-16 |
| Date Mfgr Received | 2012-05-16 |
| Date Added to Maude | 2012-05-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| 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 C701 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JLB |
| Date Received | 2012-05-30 |
| Model Number | NA |
| Catalog Number | 05641489001 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-30 |