MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-03-15 for CLINICAL CHEMISTRY PHOSPHORUS 07D71-22 manufactured by Abbott Manufacturing Inc.
[69957877]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. Patient identifier: (b)(6) udi: (b)(4) lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided.
Patient Sequence No: 1, Text Type: N, H10
[69957878]
The customer reports that one patient sample (sid (b)(6)) generated an initial elevated architect clin chem phosphorus assay result of 3. 67 mmol/l (11. 36 mg/dl). Previously, this patient had generated a result of 0. 92 mmol/l (2. 8 mg/dl). The sample was then retested with a value of 0. 98 mmol/l (3. 0 mg/dl). The sample was then tested on another architect system in the lab and generated a result of 1. 00 mmol/l (3. 1 mg/dl). No suspect results had been reported from the lab. A precision run was performed and met specifications. The sample was inspected and did contain a "high amount of floating fibrin. " there is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[73133403]
A review of complaint tracking and trending metrics was performed and identified no related adverse or non-statistical trends in conjunction with the complaint issue currently under evaluation. No non-conformances or deviations were identified. No returns were made available from the customer site. No testing was performed. A review of the architect c16000 analyzer instrument logs was performed. The history log shows numerous (61) occurrences of error code (ec) 3375 (aspiration error) from (b)(6) 2017. The maintenance log from (b)(6) shows the customer only performed as needed maintenance (6052) on february 2nd. The customer discontinued the as needed maintenance (6052) cuvette wash procedure on (b)(6) 2017, prior to the discrepant result on (b)(6) 2017. The architect clinical chemistry phosphorus assay package insert and the architect system operations manual contain information to address the current customer issue. Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product malfunction occurred. Serum and plasma samples, if not spun according to manufacturer's specifications, may generate inaccurate values. It is critical that spin times are not reduced as compensation for higher centrifuge speeds. The device met performance specifications and performed as intended at the customer site. The customer reports inspecting the sample and finding a high amount of floating fibrin in the patient serum sample. No systemic issue or product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2017-00070 |
| MDR Report Key | 6405418 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-03-15 |
| Date of Report | 2017-04-07 |
| Date Mfgr Received | 2017-04-06 |
| Device Manufacturer Date | 2016-08-31 |
| Date Added to Maude | 2017-03-15 |
| 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 | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINICAL CHEMISTRY PHOSPHORUS |
| Generic Name | PHOSPHORUS |
| Product Code | CEO |
| Date Received | 2017-03-15 |
| Catalog Number | 07D71-22 |
| Lot Number | 88136UN16 |
| Device Expiration Date | 2017-09-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-15 |