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 2017-08-30 for COBAS 8000 C 502 MODULE C502 manufactured by Roche Diagnostics.
[84009790]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[84009931]
The customer complained of erroneous results for 1 patient? S urine sample tested for albt2 tina-quant albumin gen. 2 (albt2) on a cobas 8000 c 502 module. The initial albt2 result was 318. 8 mg/l with a prozone value of 1338. A flag was not generated. This result did not fit the clinical condition of the patient so the customer decided to dilute the sample and repeat it. The result was 2993. 3 mg/l with a prozone value of 3087. A flag was not generated. The repeat result was believed to be correct. There was no allegation that an adverse event occurred. The albt2 reagent lot number was 219743 with an expiration date of 11/30/2018. The customer has set the prozone limit is set as between (-)32000 and 1300. A prozone alarm will occur if the prozone value is between these values. The prozone values related to the customer's complaint were both greater than 1300, therefore, there was no alarm. The reaction kinetics provided by the customer appear strange for the result of 318. 8 mg/l. The repeat result of 2993. 3 was performed in decreased mode and was therefore diluted. It appears that an unknown interference or high dose hook effect was diluted out causing the high prozone value. Product labeling states that when using the prozone check, no false result without a flag was observed up to an albumin concentration of 40,000 mg/l. A specific root cause for the result of 318. 8 mg/l was not identified. Additional information was requested for investigation of this result but could not be provided. The analyzer performs as it should in relation the to the prozone limit as set by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01852 |
| MDR Report Key | 6829701 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-30 |
| Date of Report | 2017-08-30 |
| Date of Event | 2017-06-21 |
| Date Mfgr Received | 2017-06-22 |
| Date Added to Maude | 2017-08-30 |
| 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 | CJW |
| Date Received | 2017-08-30 |
| 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 |
| Brand Name | COBAS 8000 C 502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-30 |
| 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 | 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 | 2017-08-30 |