MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-04-18 for COBAS 8000 SYSTEM manufactured by Roche Diagnostics.
[73074076]
Start date field - it is not known if the date provided was the date the patient started the medication or if the date provided was the date of most recent dose. This information was requested but has not been provided. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[73074077]
The customer complained of erroneous results for 1 patient sample tested for crphs cardiac c-reactiveprotein (latex) high sensitive (crphs) on a cobas 4000 c (311) stand alone system and a cobas 8000 modular analyzer used at another laboratory. This medwatch will cover the cobas 8000 system. Refer to medwatch with a1 patient identifier pt-14626 for information on the c311 system erroneous results. The initial result on the c311 system was 0. 26 mg/l. The sample was repeated and the result was 255. 19 with a data flag. The sample was repeated again on the c311 system and the result was 318. 11 mg/l with a data flag. The initial sample was sent to another laboratory using a cobas 8000 system and the results were 106. 69 mg/l and 216. 54 mg/l. There was no allegation that an adverse event occurred. The crphs reagent lot number and expiration date were not provided.
Patient Sequence No: 1, Text Type: D, B5
[132589906]
A specific root cause was not identified. No additional information related to the cobas 8000 modular analyzer used at another laboratory was provided for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00811 |
| MDR Report Key | 6501131 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-18 |
| Date of Report | 2017-08-18 |
| Date of Event | 2017-03-21 |
| Date Mfgr Received | 2017-03-23 |
| Date Added to Maude | 2017-04-18 |
| 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 8000 SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | NQD |
| Date Received | 2017-04-18 |
| Model Number | COBAS 8000 |
| Catalog Number | ASKU |
| 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 SYSTEM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-18 |
| Model Number | COBAS 8000 |
| Catalog Number | ASKU |
| 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 | 2017-04-18 |