MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-01-04 for TOTAL PROTEIN URINE/CSF GEN.3 03333825190 manufactured by Roche Diagnostics.
[63835920]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[63835921]
The customer stated that they received erroneous results for one patient cerebrospinal fluid sample tested for tpuc3 total protein urine/csf gen. 3 (tpuc) on a cobas 6000 c (501) module - c501. The specific date of the event was not provided. The date of event occurred between (b)(6) 2016. The sample initially resulted as 0. 1 mg/dl accompanied by a data flag. A second tube collected at the same time was also tested and resulted as 0. 1 mg/dl accompanied by a data flag. The 0. 1 mg/dl value was reported outside of the laboratory and was questioned by the doctor. The value was not believed to be correct based on the patient's clinical presentation. The customer expected a high value. The sample was sent to a reference laboratory where it was tested, resulting as 115 mg/dl. The result from the reference laboratory was believed to be correct and an amended report was sent to the doctor once this result was received. It was asked, but it is not known if the patient was adversely affected. No adverse events were alleged. The c501 analyzer serial number was (b)(4). The field service engineer could not determine a cause. He inspected the analyzer. He checked the fluid system and throughput of reagent and sample pipetting. He checked the gear pump and photometrics; these were ok. He checked alignments and verified rinse volumes; these were ok. He reviewed maintenance logs. He performed a precision study and all values were determined to be within range. The analyzer was found to be operating within specifications.
Patient Sequence No: 1, Text Type: D, B5
[66340865]
The time difference between measurements performed at the customer laboratory and the reference laboratory was approximately 2 days. The method used at the reference laboratory is a nephelometric method.
Patient Sequence No: 1, Text Type: N, H10
[68569245]
A specific root cause could not be determined based on the provided information. Calibration and control data were fine. A general reagent or hardware issue could be ruled out. As there was more than one low glucose result, the issue may be related to an issue with the sample probe, however, no alarms with respect to a probe issue were seen. There was most likely a pre-analytic sample handling issue causing foam/bubbles on the sample surface, leading to a pipetting issue. Since the sample was not collected in a gel tube and the sample is clear csf liquid, it is unlikely that fibrin strands or gel particles were present in the sample. The patient's medications are administered on a daily basis, so it would be assumed that each sample measurement would be consistently affected in the same way. It is unlikely that interference occurred one time only, especially since the repeat measurement in a reference laboratory was appropriate. This would lead to the conclusion that drug interference does not play a role. This conclusion, however, could not be confirmed based on the provided information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00011 |
| MDR Report Key | 6221612 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-04 |
| Date of Report | 2017-02-24 |
| Date of Event | 2016-12-12 |
| Date Mfgr Received | 2016-12-16 |
| Date Added to Maude | 2017-01-04 |
| 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 | TOTAL PROTEIN URINE/CSF GEN.3 |
| Generic Name | TURBIDIMETRIC, TOTAL PROTEIN |
| Product Code | JGQ |
| Date Received | 2017-01-04 |
| Model Number | NA |
| Catalog Number | 03333825190 |
| Lot Number | 15975201 |
| 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 | 2017-01-04 |