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 2017-09-15 for COBAS 8000 C 502 MODULE C502 manufactured by Roche Diagnostics.
[87310597]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[87310598]
The customer stated that they received an erroneous result for one patient sample tested for chol2 cholesterol gen. 2 (chol) on a cobas 8000 c 502 module (c502). The erroneous result was not reported outside of the laboratory. The sample initially resulted as 48. 4 mg/dl. The sample was repeated on a different analyzer, resulting as 208. 1 mg/dl. The customer trusted the 208. 1 mg/dl value. No adverse events were alleged to have occurred with the patient. The chol reagent lot number was 23624201, with an expiration date of 31-jan-2018. Quality controls were within range. The last calibration was ok. Upon review of the alarm trace, several abnormal sample aspiration alarms could be seen on the day of the event. Centrifugation time of the sample appeared to be too low. A specific root cause could not be determined based on the provided information. A general reagent problem could be ruled out since calibration and control are acceptable. It can be assumed that a pre-analytical sample handling issue is the root cause of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01992 |
| MDR Report Key | 6867909 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-15 |
| Date of Report | 2017-09-15 |
| Date of Event | 2017-08-26 |
| Date Mfgr Received | 2017-08-26 |
| Date Added to Maude | 2017-09-15 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CHH |
| Date Received | 2017-09-15 |
| Model Number | C502 |
| Catalog Number | ASKU |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-15 |