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 2017-09-05 for COBAS 8000 C 702 MODULE C702 manufactured by Roche Diagnostics.
[85647630]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[85647631]
The customer complained of an erroneous high result for 1 patient urine sample tested for tpuc3 total protein urine/csf gen. 3 (tpuc3) on a cobas 8000 c 702 module. The initial tpuc3 result was 148. 6 mg/dl. This result was reported outside of the laboratory. On (b)(6) 2017 the sample was repeated 5 times with results of 15. 7 mg/dl, 16. 7 mg/dl, 15. 2 mg/dl, 15. 6 mg/dl and 15. 5 mg/dl. There was no allegation that an adverse event occurred. The tpuc3 reagent lot number was 245521 with an expiration date of 08/31/2018. All patient results on (b)(6) 2017 were calculated by the same calibration curve and quality control (qc) results prior to all patient tests were within the acceptable range. The customer repeated all patient samples from (b)(6) 2017 and all patient sample result were normal except this one. No other tests were affected. Calibration and qc data were acceptable. The field service engineer (fse) visited the customer site and found that the reagent probe and the sample probe were dirty and cleaned them. The fse also observed that the pressure of the main pump was a little high and this was adjusted. A specific root cause was not identified. Additional information was requested for investigation but was not provided. A general reagent and hardware issue can be excluded since calibration and qc data was acceptable. The most likely root cause of the issue was due to the dirty sample probe identified by the fse. The sample probe may have transferred too much sample due to deposits on the outside of the probe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01887 |
| MDR Report Key | 6841252 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-05 |
| Date of Report | 2017-09-14 |
| Date of Event | 2017-08-10 |
| Date Mfgr Received | 2017-08-16 |
| Date Added to Maude | 2017-09-05 |
| 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 C 702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JGQ |
| Date Received | 2017-09-05 |
| Model Number | C702 |
| 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 C 702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-09-05 |
| Model Number | C702 |
| 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 | 2017-09-05 |