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 C 502 MODULE C502 05964067001 manufactured by Roche Diagnostics.
[73075479]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[73075480]
The customer received a questionable tpuc3 total protein urine/csf gen. 3 result for one patient urine sample. The initial result by a qualitative method was negative. No specific result data was provided. The same specimen was tested on the cobas 8000 c 502 module and the results were 111 mg/dl and 109 mg/dl. The customer did not know which result was correct. Information concerning if any erroneous result was reported outside the laboratory was requested, but it was not provided. There was no allegation of an adverse event. The reagent lot number was 189251. The expiration date was requested but was not provided.
Patient Sequence No: 1, Text Type: D, B5
[76653522]
Review of the provided reaction kinetics confirmed there was a direct interference due to the turbidity of the sample. On (b)(6) 2017, the patient had another sample tested and the result was 109 mg/l. The sample was retested by a reagent manufactured by (b)(4) and the result was 14 mg/l.
Patient Sequence No: 1, Text Type: N, H10
[79156373]
The analyzer was checked and no problem was found with the sample or reagent probes. Additional information was provided that the physician had suspected the reported result. The method used for the qualitative testing was "arkray aution eleven aution sticks 10ea".
Patient Sequence No: 1, Text Type: N, H10
[117968033]
Additional information was provided that the patient specimen did not include bence-jones protein or "other m proteins". The medications taken by the patient were reviewed and only salazosulfapyridine was a potential interference as it is comparable to phenazopyridine which interferes with the assay at a concentration of 300 mg/l. The other drugs administered to the patient were not believed to interfere.
Patient Sequence No: 1, Text Type: N, H10
[132588887]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. The turbidity of the sample or other discoloration were the most likely root causes. A drug interference was excluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00805 |
| MDR Report Key | 6500059 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-18 |
| Date of Report | 2017-12-15 |
| Date of Event | 2017-03-28 |
| Date Mfgr Received | 2017-03-30 |
| 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 C 502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JGQ |
| Date Received | 2017-04-18 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| 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 502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-18 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| 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 |