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 2017-10-24 for ALB2 ALBUMIN GEN.2 03183688122 manufactured by Roche Diagnostics.
[90874986]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90874987]
The customer stated that they received erroneous results for one patient sample tested for alb2 albumin gen. 2 (alb) on two cobas 6000 c (501) module - c501 analyzers. An erroneous result was reported outside of the laboratory to the patient and the physician. The sample initially resulted as 37. 1 g/l. The sample was repeated on a second c501 analyzer, resulting as 37. 4 g/l. The sample was repeated on an abbott architect analyzer, resulting as 26. 4 g/l. The physician indicated that the low result obtained with the architect analyzer was more in line with the medical state of the patient and the electrophoresis results of the patient. No adverse events were alleged to have occurred with the patient. The serial numbers of the c501 analyzers were asked for, but not provided. A specific root cause could not be determined based on the provided information. Additional information required for the investigation was requested, but not provided. It was assumed that blood proteins related to gammopathy were present in the sample and interfered with the alb assay. As no sample was available, further investigations were not possible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02410 |
| MDR Report Key | 6973170 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-24 |
| Date of Report | 2017-10-24 |
| Date of Event | 2017-10-09 |
| Date Mfgr Received | 2017-10-09 |
| Date Added to Maude | 2017-10-24 |
| 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 | ALB2 ALBUMIN GEN.2 |
| Generic Name | BROMCRESOL GREEN DYE-BINDING, ALBUMIN |
| Product Code | CIX |
| Date Received | 2017-10-24 |
| Model Number | NA |
| Catalog Number | 03183688122 |
| Lot Number | 267122 |
| ID Number | NA |
| Device Expiration Date | 2018-10-31 |
| 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 | 2017-10-24 |