MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-30 for ALB2 ALBUMIN GEN.2 03183688122 manufactured by Roche Diagnostics.
[76391719]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76391720]
The customer stated that they received erroneous results for two patient samples tested for alb2 albumin gen. 2 (alb) on two cobas 6000 c (501) module - c501 analyzers. The erroneous results were reported outside of the laboratory. The patient samples were collected intravenously and not from a cannula connected to these dialysis patients. There was no problem with all other tests run on the samples. The first sample was tested twice on the customer's c501 analyzer and resulted as 0. 20 g/dl accompanied by a data flag. The sample was repeated on a c501 analyzer from another laboratory and resulted with a value that was less than the measuring range of the assay and was accompanied by a data flag. The sample was repeated twice on a vitros analyzer, resulting as 2. 32 g/dl and 2. 53 g/dl. The second sample, from a (b)(6) year old male patient, was tested twice on the customer's c501 analyzer on (b)(6) 2017 and resulted as 0. 20 g/dl accompanied by a data flag. The sample was repeated on a c501 analyzer from another laboratory and resulted with a value that was less than the measuring range of the assay and was accompanied by a data flag. The sample was repeated on a vitros analyzer, resulting as 2. 3 g/dl. No adverse events were alleged to have occurred with the patients. The customer's c501 analyzer serial number was (b)(4). The serial number of the c501 analyzer used at the other laboratory was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
[117729894]
A specific root cause could not be determined based on the provided information. There was no additional sample volume remaining for further investigation. Additional information required for the investigation was requested, but not provided. Possible root causes relate to the following: -pre-analytic sample handling, -the presence of an interferent in the sample (gammopathy or unknown interferent) , causing interference with the roche assay , -foam/bubbles on the sample surface, -no pipetting of reagent, -electrical discharge in the sample probe due to < 30% humidity within the laboratory, -misalignment of the sample cup/tube due to sample probe mis-adjustment. -non use of rack adapters for sample cups. The vitros assay may yield a different result due to different methodology. Upon review of the alarm trace, an abnormal sample aspiration alarm was observed on the date of the event. A drug interference with the roche assay is not likely.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01106 |
| MDR Report Key | 6597943 |
| Date Received | 2017-05-30 |
| Date of Report | 2017-06-27 |
| Date of Event | 2017-05-02 |
| Date Mfgr Received | 2017-05-09 |
| Date Added to Maude | 2017-05-30 |
| 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 | 2017-05-30 |
| Model Number | NA |
| Catalog Number | 03183688122 |
| Lot Number | 214793 |
| 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 | 2017-05-30 |