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 2017-04-14 for COBAS 4000 C (311) STAND ALONE SYSTEM C311 04826876001 manufactured by Roche Diagnostics.
[72881938]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[72881939]
The customer received a questionable chol2 cholesterol gen. 2 result for one patient sample. A lipid panel was performed on the patient sample in the morning and the result obtained for cholesterol was 129 mg/dl. This result was reported outside the laboratory. The doctor called the laboratory questioning the result as it did not agree with the previous results for the patient. The sample was repeated on another cobas 4000 c (311) stand alone system and the result was 219 mg/dl. This result agreed with the patient? S other cholesterol results. The patient was not treated based on the incorrect result. There was no adverse event. The reagent lot number was 17931201. The expiration date was requested but was not provided. The repeat results for the other assays in the lipid panel matched the previous results. The customer mentioned they had an issue with a creatinine result for another sample, but stated the sample was found to contain clots. The customer performed 10 probe washes after this sample. The field service representative could not find a cause. He ran an instrument precision check with all results within specifications.
Patient Sequence No: 1, Text Type: D, B5
[132586030]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. As the customer was not following the tube manufacturer's recommendation for clotting time, a preanalytic issue was suspected. Based on the calibration and qc data provided, an instrument or reagent problem was ruled out. The customer was not aware of any further issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00784 |
| MDR Report Key | 6493975 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-14 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-03-30 |
| Date Mfgr Received | 2017-03-30 |
| Date Added to Maude | 2017-04-14 |
| 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 |
| 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 4000 C (311) STAND ALONE SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CHH |
| Date Received | 2017-04-14 |
| Model Number | C311 |
| Catalog Number | 04826876001 |
| 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 4000 C (311) STAND ALONE SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-14 |
| Model Number | C311 |
| Catalog Number | 04826876001 |
| 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 | 2017-04-14 |