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 2017-10-16 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[90465853]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[90465854]
The customer stated that they had questionable test results for two patient samples tested on the cobas 6000 c (501) module that generated sample short alarms. Of these two samples, one had an erroneous result for chol2 cholesterol gen. 2 (chol). This sample initially resulted with a chol value of 8 mg/dl. The result was reported outside of the laboratory, but was caught by lab personnel right away and re-called. The result was not reported to the patient or to medical personnel treating the patient. The sample was repeated, resulting as 242 mg/dl. The patient was not adversely affected. Other test results on the same sample were believed to be correct. The customer stated that serum from the primary tube was poured off into a pour-off tube. The customer stated that the sample volume in the pour off tube was not low. The customer was concerned about the analyzer flagging this sample since the sample volume was not low. The chol reagent lot number was 21725701, with an expiration date of 31-oct-2017. The field service engineer replaced the sample probe. He ran precision studies. Diagnostics were performed without errors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02320 |
| MDR Report Key | 6951230 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-16 |
| Date of Report | 2017-11-02 |
| Date of Event | 2017-09-26 |
| Date Mfgr Received | 2017-09-29 |
| Date Added to Maude | 2017-10-16 |
| 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 | 0 |
| 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 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CHH |
| Date Received | 2017-10-16 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-16 |