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 2017-08-01 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[81525899]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[81525900]
The customer stated that they received an erroneous result for one patient sample tested for hdlc3 hdl-cholesterol plus 3rd generation (hdl) on a cobas 6000 c (501) module - c501. The erroneous result was not reported outside of the laboratory. The customer stated that other patient samples resulted normally. The customer believed the issue to be related to the instrument as it had happened before in the past. No further details were provided regarding this previous event. The sample initially resulted as 113 mg/dl. The sample was repeated on a different analyzer, resulting as 43 mg/dl. No treatment was provided to the patient since no erroneous result was reported outside of the laboratory. No adverse events were alleged to have occurred with the patient. The hdl reagent lot number was 200767, with an expiration date of 07/31/2018. The reagent had been in use on the analyzer since (b)(6) 2017. The field service engineer found contamination in the instrument. He performed a decontamination of the instrument. He cleaned the circulation paths, including the air trap and lamp holder. He replaced a valve. He ran photometric tests and these passed. The customer ran quality controls and these were within laboratory specifications. Precision studies were performed and these were within specification. The customer also noted that the engineer cleaned the incubator bath and informed the customer that there could potentially be an issue with the mixing station. Parts were ordered to replace the mixing station.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01577 |
| MDR Report Key | 6757468 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-01 |
| Date of Report | 2017-09-06 |
| Date of Event | 2017-07-12 |
| Date Mfgr Received | 2017-07-13 |
| Date Added to Maude | 2017-08-01 |
| 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 | 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 | LBS |
| Date Received | 2017-08-01 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-01 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 | 2017-08-01 |