MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-10-09 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[3066251]
The field application specialist (fas) reported the customer received a questionable hdl cholesterol result for one patient sample. No other erroneous results were generated on this or any other sample. The initial result was 1 mg/dl and was converted by the customer's laboratory information system (lis) to <4 mg/dl and reported outside the laboratory. The physician called to question the validity of the hdl result. The customer pulled the same parent tube which was used for original testing and retested all lipid assays. The retest hdl result from the same tube was 35 mg/dl. The same tube was also tested on an integra 800 analyzer serial number 39-6005 and the result was 33 mg/dl. The repeat result was believed to be correct. The patient did not suffer any adverse event. The hdl reagent lot number was 66068701 with an expiration date of 01/31/2014. The customer declined a service visit.
Patient Sequence No: 1, Text Type: D, B5
[10244811]
The investigation could not determine a specific root cause. Based on the imprecision demonstrated in the provided qc data, a general instrument maintenance issue was suspected. It was also noted the customer was using sample tubes containing sodium heparin. This is not an allowed anticoagulant per product labeling.
Patient Sequence No: 1, Text Type: N, H10
[10278572]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-05034 |
| MDR Report Key | 2776962 |
| Report Source | 05,06,07 |
| Date Received | 2012-10-09 |
| Date of Report | 2012-10-24 |
| Date of Event | 2012-10-02 |
| Date Mfgr Received | 2012-10-02 |
| Date Added to Maude | 2012-10-09 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 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 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LBR |
| Date Received | 2012-10-09 |
| Model Number | NA |
| Catalog Number | 05860636001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2012-10-09 |