MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-19 for ALBUMIN TINA-QUANT ALBUMIN 03576108190 manufactured by Roche Diagnostics.
[63191311]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[63191312]
The customer stated that they received an erroneous result for one patient urine sample tested for albumin tina-quant albumin (malb) on a jca-bm8040 analyzer (manufactured by jeol). The sample initially resulted as 3497. 3 mg/dl and this value was reported outside of the laboratory. The result was questioned by a physician. The customer also stated that the result differed from a previous sample tested on (b)(6) 2016. The value of the previous sample could not be provided. The sample was then diluted 100 times and tested, resulting with a final calculated value of 3500 mg/dl. The sample was diluted 200 times and tested, resulting with a final calculated value of 1720 mg/dl. The sample was diluted 400 times and tested, resulting with a final calculated value of 1400 mg/dl. The sample was also diluted 800 times and tested, resulting with a final calculated value of 640 mg/dl. The customer did not know which result was correct. The patient was not adversely affected.
Patient Sequence No: 1, Text Type: D, B5
[67567178]
Preliminary investigations performed with the affected patient sample and the sample collected from the patient on (b)(6) 2016 prior to the fluorescite treatment showed linearity until 800 fold dilution.
Patient Sequence No: 1, Text Type: N, H10
[68569242]
Investigations have determined that the fluorescine does not have any impact on the measured results. A specific root cause could not be determined based on the provided information. Additional information required for the investigation was requested, but not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01984 |
| MDR Report Key | 6184883 |
| Date Received | 2016-12-19 |
| Date of Report | 2017-02-24 |
| Date of Event | 2016-12-06 |
| Date Mfgr Received | 2016-12-06 |
| Date Added to Maude | 2016-12-19 |
| 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 | ALBUMIN TINA-QUANT ALBUMIN |
| Generic Name | INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) |
| Product Code | JIR |
| Date Received | 2016-12-19 |
| Model Number | NA |
| Catalog Number | 03576108190 |
| Lot Number | 139356 |
| ID Number | NA |
| Device Expiration Date | 2017-12-31 |
| 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 | 2016-12-19 |