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 2018-08-10 for ALBT2 TINA-QUANT ALBUMIN GEN.2 04469658190 manufactured by Roche Diagnostics.
[117163615]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[117163616]
The customer stated that they received an erroneous result for one 24 hour urine patient sample tested for albt2 tina-quant albumin gen. 2 on a cobas integra 400 plus (i400+). The sample initially resulted with an albt2 value of 144. 182 mg/l and this value was reported outside of the laboratory to the patient. The patient questioned the result since it was elevated and a physician asked for a repeat of the sample. The sample was repeated on (b)(6) 2018, resulting as 148. 331 mg/l. The sample was diluted (dilution factor unknown) and repeated five more times on (b)(6) 2018, resulting as 1234. 98 mg/l, 1283. 99 mg/l, 1278. 84 mg/l, 1295. 05 mg/l, and 1270. 67 mg/l. The sample was diluted 1:10 and repeated on (b)(6) 2018, resulting as 1301. 479 mg/l. No adverse events were alleged to have occurred with the patient. The serial number of the i400+ was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02689 |
| MDR Report Key | 7773678 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-10 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-07-23 |
| Date Mfgr Received | 2018-07-26 |
| Date Added to Maude | 2018-08-10 |
| 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 |
| 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 | 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 | ALBT2 TINA-QUANT ALBUMIN GEN.2 |
| Generic Name | ALBUMIN, ANTIGEN |
| Product Code | DCF |
| Date Received | 2018-08-10 |
| Model Number | NA |
| Catalog Number | 04469658190 |
| Lot Number | 32279101 |
| 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 | 2018-08-10 |