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 2017-08-21 for COBAS 8000 C 502 MODULE C502 05964067001 manufactured by Roche Diagnostics.
[83946297]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[83946298]
The customer received questionable low results for qc samples tested in a microcups since (b)(6) 2017 and for one patient sample tested for alp on (b)(6) 2017. The initial result was 6. 1 u/l and was reported outside the laboratory. When the customer noticed the low result, they repeated the sample with a result of 276. 3 u/l. The customer immediately called the doctor. There was no allegation of an adverse event. The reagent lot number was 215968. The expiration date was requested but was not provided. The field service representative found the sample probe was misadjusted on the cuvette and sample pipetting position. The investigation determined it was very likely that the probe was hitting the side of the cup before touching the sample which confused the liquid level detection (lld). This resulted in very little or no sample being pipetted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01767 |
| MDR Report Key | 6806929 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-21 |
| Date of Report | 2017-08-21 |
| Date of Event | 2017-08-01 |
| Date Mfgr Received | 2017-08-01 |
| Date Added to Maude | 2017-08-21 |
| 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 502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CJO |
| Date Received | 2017-08-21 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-21 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-08-21 |