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 2016-02-15 for IRON, GEN.2 03183696122 manufactured by Roche Diagnostics.
[38228308]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[38228309]
The customer reported that they had an issue with iron gen. 2 (iron) reagent cassettes on c501 analyzers at two different sites. An unspecified number of patient samples suddenly had results below 2 umol/l or had negative values. The date of the event was asked for, but not provided. At the first site, quality controls were measured a few hours before the incident and these were fine. The customer ran patient samples using iron cassette lot number 617429. It was stated that the first few samples were ok, but suddenly, the rest of the samples were measured with very low or negative results. No erroneous results were released outside of the laboratory. Quality controls were measured again and showed negative results. The software showed that 40 of the 200 tests in the cassette should be left. When the cassette was dumped, it seemed like it was empty. A new cassette was loaded and everything was fine. Samples were repeated. No specific data was provided from the first site. At the second site ((b)(6) hospital), they first became aware of the issue when they encountered negative quality control results on (b)(6) 2016. The customer was using iron cassette lot number 621897. The customer tried to calibrate the test, but received an error. All samples measured before the negative controls were repeated and some of the samples had results < 2 umol/l. The reagent cassette was examined and one bottle in the cassette was empty. There was very little reagent left in a second cassette bottle. The software showed that there were 55 tests left in the cassette. A new reagent cassette was loaded, controls were run on it, and everything was ok. The customer checked the weight of their remaining iron cassettes and everything seemed to be ok. One sample from the second site had an erroneous result that was reported outside of the laboratory. The sample initially resulted as -2 umol/l and this value was reported outside of the laboratory. The sample was repeated, resulting as 8. 3 umol/l. The erroneous result was corrected. It was asked, but it is not known if the patient was adversely affected. No adverse events were alleged. The c501 analyzer serial number from the second site was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
[39232419]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[50736979]
A specific root cause could not be determined based on the provided information. Additional information required for the investigation was requested, but not provided. In most cases, the observed issue would be related to incorrect sample preparation, sample probe pipetting precision, or incomplete maintenance of the analyzer. An analyzer related issue may be excluded due to reproducibility of control values.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00148 |
| MDR Report Key | 5436471 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-15 |
| Date of Report | 2016-07-18 |
| Date of Event | 2016-01-14 |
| Date Mfgr Received | 2016-01-19 |
| Date Added to Maude | 2016-02-15 |
| 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 | 2016-02-15 |
| Model Number | NA |
| Catalog Number | 03183696122 |
| Lot Number | 621897 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-15 |