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 2017-05-16 for ELECSYS PROBNP II STAT IMMUNOASSAY 05390109160 manufactured by Roche Diagnostics.
[75258302]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75258303]
The customer stated that they continually have high elecsys troponin t stat assay (tnt-stat) and/or elecsys probnp ii stat immunoassay (probnp) results with data flags on heel stick samples from neonates. The customer provided example data for 14 neonates. Of the data provided, the customer questioned high results for one neonate patient due to the results not matching the patient's clinical status. No alarms or error messages were provided by the customer for these results. The patient was in the emergency department when the samples were taken, and the samples were hemolyzed. This medwatch is for the probnp results. Refer to medwatch with a1 patient identifier pt-15129 for the tnt-stat results. On (b)(6) 2017, the initial tnt-stat result from a heel stick sample was 0. 102 ng/ml. The initial probnp result was 4180 pg/ml. On (b)(6) 2017, the tnt-stat result from a venipuncture sample was 0. 091 ng/ml. The probnp result was 5167 pg/ml. The patient was diagnosed with rapid breathing. The results were released to the physician, who questioned them as they did not fit the patient's clinical picture. The patient was then airlifted to a second hospital due to the elevated results. A new sample was taken at the second hospital. The laboratory staff performed a troponin i assay on an istat device with a result of 0. 07 ng/ml. This result was within the normal range for neonates and was deemed correct. The patient was discharged from the second hospital without incident. The patient is currently fine. The cobas 6000 e 601 module (e601) serial number is (b)(4). Qc was acceptable on the date of the event. The customer sent out a sample to a reference laboratory for confirmation tnt-stat testing, and the results were "high" and matched what they obtained on the e601. Specific data were not provided. The customer was using standard roche false bottom sample tubes which were configured for the analyzer. The field service representative ran performance tests on the analyzer, and all results were within specifications. Investigation activities are ongoing.
Patient Sequence No: 1, Text Type: D, B5
[114860606]
A specific root cause for this event could not be identified. Additional information was requested for investigation but was not provided. Information and published references were provided to the customer to support that the elevated results provided for tnt-stat and probnp are plausible for neonates. Multiple attempts made to reach the customer, but none were successful. Tnt-stat and troponin i assays are different methods, and the results are not necessarily related to each other. Published literature provides clinical explanations for this difference. There was no information to indicate that the results were incorrect.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01016 |
| MDR Report Key | 6569331 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-16 |
| Date of Report | 2017-06-21 |
| Date of Event | 2017-04-18 |
| Date Mfgr Received | 2017-04-19 |
| Date Added to Maude | 2017-05-16 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | ELECSYS PROBNP II STAT IMMUNOASSAY |
| Generic Name | TEST, NATRIURETIC PEPTIDE |
| Product Code | NBC |
| Date Received | 2017-05-16 |
| Model Number | NA |
| Catalog Number | 05390109160 |
| Lot Number | ASKU |
| 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 | 2017-05-16 |