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 2016-01-12 for TOTAL PROTEIN URINE/CSF GEN.3 03333825190 manufactured by Roche Diagnostics.
[35685897]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[35685898]
The customer complained of erroneous results for 1 patient tested for total protein urine/csf gen. 3 (tpuc3). The patient is a diabetic who had come to the clinic for his annual check-up. Part of this check-up is a fluo-angiography of the eyes to check for diabetic retinopathy and a urine analysis to check for diabetic nephropathy. The patient was treated with fluorescein for the fluo-angiography. The fluo-angiography was performed at approximately 2:00 p. M. The urine sample was received in the laboratory the same day at approximately 4:05 p. M. The tpuc3 result was high and did not correspond to the patient? S clinical picture based on a blood analysis performed in (b)(6) 2015. The patient? S renal function is still perfect and the high protein in the urine was not expected. The customer believes the fluorescein caused the high result. The customer is wondering if fluorescein is an interference affecting the tpuc3 result. The erroneous result was reported outside of the laboratory to the physician with a statement that an interference with the assay may have influenced the result. The initial tpuc3 result using a urine sample was 3. 994 g/l. The value from the siemens albustix was negative and the urine result for microalbumin was 53 mg/l. The microalbumin results are believed to be correct. On (b)(6) 2015 the customer performed a dilution series with the urine sample and the following results were received: dilution 2x albumin 63. 8 mg/l (31. 9 mg/l) tpuc3 3. 788 g/l (1. 894 g/l), dilution 4x albumin 54. 4 mg/l (13. 6 mg/l) tpuc3 4. 06 g/l (1. 015 g/l), dilution 8x albumin 48. 0 mg/l (6. 0 mg/l) tpuc3 4. 832 g/l (0. 604 g/l), dilution 16x albumin 28. 8 mg/l (1. 8 mg/l) tpuc3 5. 968 g/l (0. 373 g/l), dilution 32x albumin 22. 4 mg/l (0. 7 mg/l) tpuc3 7. 456 g/l (0. 233 g/l), dilution 64x albumin 6. 4 mg/l (0. 1 mg/l) tpuc3 9. 28 g/l (0. 145 g/l). On (b)(6) 2015 the urine sample was concentrated 200x and protein electrophoresis was performed with the following results: albumin 56. 4%, alpha 1 8. 8%, alpha 2 11. 2%, beta 9. 7%, gamma 13. 9% and an a/g ratio of 1. 29. Based on the results of the protein electrophoresis that indicated that 56. 4% of the total protein was albumin, the expected total protein in the sample would be 0. 094 g/l. No adverse event occurred. The c501 analyzer serial number was not provided.
Patient Sequence No: 1, Text Type: D, B5
[39376781]
Product labeling indicates that samples for urinary/csf protein should be collected before fluorescein is given or at least 24 hours later.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00039 |
| MDR Report Key | 5360769 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-01-12 |
| Date of Report | 2016-03-01 |
| Date of Event | 2015-12-15 |
| Date Mfgr Received | 2015-12-28 |
| Date Added to Maude | 2016-01-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOTAL PROTEIN URINE/CSF GEN.3 |
| Generic Name | TURBIDIMETRIC, TOTAL PROTEIN |
| Product Code | JGQ |
| Date Received | 2016-01-12 |
| Model Number | NA |
| Catalog Number | 03333825190 |
| Lot Number | ASKU |
| 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 | 2016-01-12 |