MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-18 for PROTEUS DISCOVER manufactured by Proteus Digital Health, Inc.
[114297724]
Case (b)(4) is a report originating from post market study: "(pb-wotforhepc evaluation of wirelessly observed therapy to optimize adherence in patients with hepatitis c and increased high risk for nonadherence to treatment)" received from a physician which concerns a black or asian african female patient (subject (b)(6)) who utilized proteus discover (components: ingestible sensor (is) and wearable sensor (ws) and died due to unknown cause after the end of therapy. Current conditions included (b)(6) (started in: 2003), iv (intravenous) drug abuse, asthma (started in: 2015), facet arthropathy (started in: 2015), copd (chronic obstructive pulmonary disease) (started in: 2015), depression (started in: 2016), bipolar disease (started in: 2016), heart murmur, immune deficiency disorder, insomnia, nonepileptic episode, pneumocystis carinii pneumonia, post-traumatic stress disorder. Patient underwent smoking cessation. Past medical history was not reported. Concomitant medications included (b)(6) 600/50/300 mg tablets at one tablet by mouth daily for (b)(6), depakote er (divalproex) 500 mg 24 hour tablets at 2 tablets (1,000 mg per dose) by mouth nightly, harvoni (ledipasvir, sofosbuvir) 90 mg-400 mg per tablet at one tablet by mouth daily, narcan (naloxone) 4 mg/actuation nasal spray sprayed into one nostril for suspected overdose and repeated for one time if there was no response after 3 minutes, seroquel (quetiapine) 100 mg tablets at one tablet (100 mg per dose) by mouth nightly taken along with 50 mg tablet for depression, seroquel (quetiapine) 50 mg tablets at one tablet (50 mg per dose) by mouth nightly and taken along with 100 mg tablet for depression, suboxone (buprenorphine, naloxone) 8-2 mg sublingual film, ventolin hfa (albuterol sulfate) 90 mcg/actuation inhaler at 2 puffs inhaled into the lungs every six hours as needed for wheezing, asthma/copd, nicotine transdermally for smoking cessation. On (b)(6) 2018, the patient first used the study drug, ingestible sensor (is) and wearable sensor (ws). On (b)(6) 2018, patient's (b)(6). On (b)(6) 2018, patient's blood pressure was 129/77 and (b)(6). On (b)(6) 2018, patient's blood pressure was 128/88 and (b)(6). On (b)(6) 2018, the patient had taken the most recent dose of study drug and completed (b)(6) treatment. It was reported that the patient had not experienced adverse event associated with study device or (b)(6) medications. On (b)(6) 2018, patient's blood pressure was 100/69 and (b)(6). On an unknown date, patient's ascvd (atherosclerotic cardiovascular disease) score was 0. 9%, systolic bp (blood pressure) was 100, hdl (high density lipoprotein) was 51 mg/dl and total cholesterol was 197 mg/dl. On (b)(6) 2018, patient died in her sleep and cause of death was unknown. It was reported that the patient's husband returned home from work and found patient dead on the bed. The bed was clean and bedding was made up and patient's husband had not seen anything at her bedside that was suspicious. It was reported that the patient's husband had called police and they attended to the scene. There was no foul play and patient's body was sent to (b)(6) funeral home (b)(6). It was also reported that the autopsy was not performed. It was reported that patient was awaiting week 12 svr laboratory testing (sustained viral response) due in (b)(6) 2018. Outcome of event was fatal. The investigator assessed the event as severe in intensity. The investigator assessed the event to be not related to study drug and study device. It was reported that the specific etiology of event was not known. This case was considered serious as the event was fatal. Company comment: this case was considered serious as the event was fatal. Death is an unexpected ae. Based on information received and in agreement with the investigator, the causality for the event is assessed as not related to the study drug, suspect device and/or study procedure.
Patient Sequence No: 1, Text Type: N, H10
[114297725]
Sae: death due to unknown cause (verbatim). Meddra code: unknown cause of death. Causality assessed by investigator: unrelated. Date of death: (b)(6) 2018. Outcome: fatal. Intensity: severe. Company causality: unrelated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008597490-2018-00012 |
| MDR Report Key | 7697736 |
| Date Received | 2018-07-18 |
| Date of Report | 2018-07-17 |
| Date of Event | 2018-06-26 |
| Date Added to Maude | 2018-07-18 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTEUS DISCOVER |
| Generic Name | PROTEUS DISCOVER (WEARABLE SENSOR, INGESTIBLE SENSOR) |
| Product Code | OZW |
| Date Received | 2018-07-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROTEUS DIGITAL HEALTH, INC |
| Manufacturer Address | 2600 BRIDGE PARKWAY SUITE 101 REDWOOD CITY CA 94065 US 94065 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-07-18 |