MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2014-12-17 for TOTAL PROTEIN 04657586190 manufactured by Roche Diagnostics.
[5178878]
The customer reported that they received questionable high total protein results for a total of 15 patient samples when compared to results from a biosystems bts-350 analyzer. Of the 15 samples, eight of these had erroneous results. The customer stated that they switched to a new reagent lot number and then obtained the correct results for patient samples. The first patient sample initially resulted as 80. 8 g/l on the c111 analyzer. The sample was repeated on the biosystems bts-350 analyzer and resulted as 67. 3 g/l. The second patient sample initially resulted as 80. 2 g/l on the c111 analyzer. The sample was repeated on the biosystems bts-350 analyzer and resulted as 67. 9 g/l. The third patient sample initially resulted as 86. 4 g/l on the c111 analyzer. The sample was repeated on the biosystems bts-350 analyzer and resulted as 75. 6 g/l. The fourth patient sample initially resulted as 87 g/l on the c111 analyzer. The sample was repeated on the biosystems bts-350 analyzer and resulted as 76. 5 g/l. The fifth patient sample initially resulted as 82. 9 g/l on the c111 analyzer. The sample was repeated on the biosystems bts-350 analyzer and resulted as 69 g/l. The sixth patient sample initially resulted as 82. 9 g/l on the c111 analyzer. The sample was repeated on the biosystems bts-350 analyzer and resulted as 69. 5 g/l. The seventh patient sample initially resulted as 86. 3 g/l on the c111 analyzer. The sample was repeated on the biosystems bts-350 analyzer and resulted as 75. 3 g/l. The eighth patient sample initially resulted as 83. 1 g/l on the c111 analyzer. The sample was repeated on the biosystems bts-350 analyzer and resulted as 67. 5 g/l. It was asked, but it is not known if any erroneous results were reported outside of the laboratory. A clarification has been requested. It was asked, but it is not known if any patients were adversely affected. No adverse events were alleged. A c111 instrument serial number of (b)(4) was provided, but it is not clear if this is the actual serial number of the instrument used at this site. A clarification has been requested.
Patient Sequence No: 1, Text Type: D, B5
[12620419]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[14215193]
Comparison studies have been performed as a part of the investigation. Preliminary investigations have been able to verify the customer's complaint.
Patient Sequence No: 1, Text Type: N, H10
[19521605]
It was confirmed that no patients were adversely affected.
Patient Sequence No: 1, Text Type: N, H10
[19524583]
The correct c111 analyzer serial number used at this site has been confirmed to be (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[31054154]
It was determined that during the preliminary investigation method comparisons, samples used for the investigation measurements were not centrifuged prior to measurement. The customer's complaint was verified at that time. Labeling indicates that samples containing precipitates should be centrifuged prior to measurement. The total protein assay is very sensitive to precipitates in human samples. Investigation measurements were later performed with samples that had been centrifuged and results from these samples were within specifications. A specific root cause for the customer's issue could not be identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-10072 |
| MDR Report Key | 4338515 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2014-12-17 |
| Date of Report | 2015-10-23 |
| Date of Event | 2014-10-20 |
| Date Mfgr Received | 2014-10-31 |
| Date Added to Maude | 2014-12-30 |
| 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 |
| 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 | TOTAL PROTEIN |
| Generic Name | BIURET (COLORIMETRIC), TOTAL PROTEIN |
| Product Code | CEK |
| Date Received | 2014-12-17 |
| Model Number | NA |
| Catalog Number | 04657586190 |
| Lot Number | 692946 |
| 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 | 2014-12-17 |