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 2017-08-07 for COBAS 8000 C 702 MODULE C702 06473245001 manufactured by Roche Diagnostics.
[83232918]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83232919]
The customer stated that they have been having issues with an unspecified number of patient samples tested for hdlc3 hdl-cholesterol plus 3rd generation (hdl) on a cobas 8000 c 702 module (c702). Samples will initially result with a low value and then when repeated, the value is much higher. The issue is intermittent and does not occur with every patient sample. The customer provided examples of three patient samples which had erroneous initial hdl results that were reported outside of the laboratory. Samples were repeated on an unknown analyzer and repeat results were believed to be correct. The first sample initially resulted as approximately 6 mg/dl and repeated as approximately 61 mg/dl. The second sample initially resulted as 11 mg/dl on (b)(6) 2017. The sample was repeated twice, resulting as 81 mg/dl and 84 mg/dl. The third sample initially resulted as 15 mg/dl on (b)(6) 2017 and repeated as 74 mg/dl. No adverse events were alleged to have occurred with the patients. The hdl reagent lot number was 16307001, with an expiration date of 04/30/2018. The field service engineer determined that a probe was misaligned. He aligned the probe to the wash station. He adjusted the reagent wash and rinse volumes. He ran precision studies. The customer ran quality controls and these were within range.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01631 |
| MDR Report Key | 6771151 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-07 |
| Date of Report | 2017-09-05 |
| Date of Event | 2017-07-14 |
| Date Mfgr Received | 2017-07-19 |
| Date Added to Maude | 2017-08-07 |
| 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 8000 C 702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LBS |
| Date Received | 2017-08-07 |
| Model Number | C702 |
| Catalog Number | 06473245001 |
| 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 8000 C 702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-07 |
| Model Number | C702 |
| Catalog Number | 06473245001 |
| 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 | 2017-08-07 |