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 2017-03-21 for IRON GEN.2 03183696122 manufactured by Roche Diagnostics.
[70489668]
Facility name continued - (b)(4). This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[70489669]
The customer is questioning low results for 2 patients tested for iron2 iron gen. 2 (iron2) on a cobas integra 800. The customer had reported iron2 results for 2 patients outside of the laboratory where the results were questioned by the clinical doctor. Since the clinical doctor questioned the results, the customer decided to perform a method comparison with 30 patient samples between the integra 800 instrument and a hitachi 7600 analyzer using a wako reagent. Based on the comparison data provided, the results for these 2 patients were erroneous. No other erroneous results were reported outside of the laboratory. Patient 1 initial iron2 result was 99 ug/dl on the integra 800. The repeat result from the hitachi 7600 analyzer using wako reagent was 296 ug/dl. Patient 2 (female) initial iron2 result was 120 ug/dl on the integra 800. The repeat result from the hitachi 7600 analyzer using wako reagent was 442 ug/dl. There was no allegation that an adverse event occurred. These patients were taking iron supplements so the customer was aware the iron2 results could be low due to this. The customer is wondering why the wako reagent is not affected the same way. Product labeling indicates that the iron2 test is affected when patients are treated with iron supplements or metal-binding drugs. In these patients, the drug-bound iron may not properly react with the reagent, which can cause low results. Roche cannot provide information as to the specifications or performance of the wako product.
Patient Sequence No: 1, Text Type: D, B5
[118806965]
During testing, the diagnostically relevant iron bound to transferrin is released due to acidic ph and detergent in the reaction solution. Iron from other sources (hemoglobin, enzymes containing iron-sulfur clusters, etc. ) is diagnostically irrelevant and is intentionally not assessed. The drug in the supplements can bind iron from the sample. This process occurs in the patient sample apart from the analyzer, but it leads to lower iron results because the iron2 assay does not detect the drug bound iron. A product problem was not detected. The device operates per specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00600 |
| MDR Report Key | 6420522 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-21 |
| Date of Report | 2017-07-10 |
| Date of Event | 2017-03-01 |
| Date Mfgr Received | 2017-03-02 |
| Date Added to Maude | 2017-03-21 |
| 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 | IRON GEN.2 |
| Generic Name | PHOTOMETRIC METHOD, IRON (NON-HEME) |
| Product Code | JIY |
| Date Received | 2017-03-21 |
| Model Number | NA |
| Catalog Number | 03183696122 |
| Lot Number | 17599301 |
| ID Number | NA |
| Device Expiration Date | 2017-08-31 |
| 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 | 2017-03-21 |