MAUDE Adverse Event Report: FISHER DIAGNOSTICS FISHER DIAGNOSTICS TRUTOL GLUCOSE TOLERANCE TEST BEVERAGE; DRINK, GLUCOSE TOLERANCE

Catalog Number	401272P
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fisher diagnostics, located at (b)(4), has never distributed products directly to (b)(6) hospital.Mdr uf/importer report #(b)(4) has been fisher diagnostics' first receipt of any notice or report regarding this event.Fisher diagnostics became aware of this event on july 12, 2019.Upon investigation, fisher diagnostics has found no problem to be present with the labeling of the trutol glucose tolerance test beverage product as the grams of dextrose present are labeled with bold, enlarged font on two locations on each bottle label.In addition, the grams of dextrose present in the product is featured in five locations within the instructions for use on the bottle label.Furthermore, product traceability actions were carried out and the distributor, (b)(4) , was contacted to identify where the fault occurred with reference to this event.Customer ((b)(6) healthcare, which includes (b)(6) hospital) has continued to order/purchase (b)(4) product number tgp401207pa (fisher diagnostics - (b)(4) manufacturer part number 401207p) trutol glucose tolerance test beverage, orange flavor, 100g.Upon receipt of a shipment of (b)(4) product number tgp401272pa (fisher diagnostics - (b)(4) manufacturer part nmber 401272p) trutol glucose tolerance test beverage, orange flavor, 50g, a (b)(4) warehouse inventory controlled this delivery (received on 18 mar 2019) incorrectly and it was placed in the location of fisher scientific product number tgp401207pa (fisher diagnostics, manufacturer, part number 401207p) trutol glucose tolerance test beverage, orange flavor, 100g in the warehouse.Therefore, upon receipt of po # (b)(4) from partners healthcare, the warehouse picked what was believed to be tgp401207pa as it was in that part number assigned location; however, it was actually tgp401272pa (50g) that had been incorrectly placed in that location.As soon as fisher scientific became aware of this discrepancy on 18 apr 2019, that same day the inventory was corrected to prevent future mis-shipments.Although this was confirmed to be a mis-shipment by (b)(4) distribution of the wrong concentration of product shipped versus product ordered by the customer, it is still the end user's, in this case (b)(6) hospital staff's, responsibility before administration to a patient that the product provided is verified to be in accordance with the physician's order.In summary, while (b)(4) distribution contributed to these patient events, sole responsibility for the effect it had on all the patients who had to be recalled for repeat testing is on (b)(6) hospital.In conclusion, this event was in no way caused by the trutol glucose tolerance test beverage product manufacturer, fisher diagnostics.(b)(4).
Event or Problem Description
(b)(6) hospital placed an order with a distributor, (b)(4), for orange-flavored trutol glucose tolerance test beverage with 100g of dextrose.(b)(6) hospital staff discovered that they were supplied with 50g dextrose bottles instead of 100g dextrose bottles approximately one month after receipt of the product.The supplier, (b)(4), was contacted and confirmed that the aforementioned shipment to (b)(6) hospital was made in error.(b)(6) hospital notified patients who had been tested for glucose tolerance with this beverage and asked the patients to return for repeat testing.(b)(6) hospital has confirmed that there have been no adverse effects as a result of incorrect administration of the trutol glucose tolerance test beverage product.

• Brand Name: FISHER DIAGNOSTICS TRUTOL GLUCOSE TOLERANCE TEST BEVERAGE
• Common Device Name: DRINK, GLUCOSE TOLERANCE
• Manufacturer (Section D): FISHER DIAGNOSTICS; 8365 valley pike; middletown VA 22645
• MDR Report Key: 9139107
• Report Number: 1181121-2019-00001
• Device Sequence Number: 19295254
• Product Code: MRV
• UDI-Device Identifier: 00845275004090
• UDI-Public: 00845275004090
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K032753
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2019
• Report Date (Section F): 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 401272P
• Device Lot Number: 440379
• Was Device Available for Evaluation?: No
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR